Uterine fibroid tissue removal device

ABSTRACT

A uterine fibroid tissue removal device includes an inner tube disposed within an outer tube and configured to be translated and rotated relative to the outer tube, and a unitary distal tip member attached to a distal end of the inner tube such that the distal tip member translates and rotates relative to the outer tube along with the inner tube, wherein a distal facing open cutting end of the distal tip member in fluid communication with an axial lumen of the distal tip member translates across a tissue resection window in a sidewall of the outer tube so as to sever tissue extending therethrough, the distal tip member axial lumen being in fluid communication with an axial lumen of the inner tube, wherein the axial lumen of the distal tip member is smaller in cross-sectional area than the axial lumen of the inner tube, and wherein the distal tip member has a length greater than a length of the resection window.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation in part of U.S. patentapplication Ser. No. 12/098,250, filed Apr. 4, 2008 (titled “METHOD,SYSTEM AND DEVICE FOR TISSUE REMOVAL”), which claims the benefit under35 U.S.C. §119(e) of U.S. Provisional Application 60/910,618, filed Apr.6, 2007, U.S. Provisional Patent Application Ser. No. 60/910,625, filedApr. 6, 2007, and U.S. Provisional Patent Application Ser. No.60/986,912, filed Nov. 9, 2007 all of which are incorporated herein byreference. The present application is a continuation in part of U.S.patent application Ser. No. 12/098,318, filed Apr. 4, 2008 (titled“SYSTEM FOR USE IN PERFORMING A MEDICAL PROCEDURE AND INTRODUCER DEVICESUITABLE FOR USE IN SAID SYSTEM”), which claims the benefit under 35U.S.C. §119(e) of U.S. Provisional Application Ser. No. 60/910,618,filed Apr. 6, 2007, and U.S. Provisional Patent Application Ser. No.60/910,625, filed Apr. 6, 2007, all of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

The present invention relates generally to methods, systems and devicesfor the removal of tissue and relates more particularly to methods,systems, and devices well-suited for the removal of uterine fibroids andother abnormal gynecological tissues.

It is believed that uterine fibroids occur in a substantial percentageof the female population, perhaps in at least 20 to 40 percent of allwomen. Uterine fibroids are well-defined, non-cancerous tumors that arecommonly found in the smooth muscle layer of the uterus. In manyinstances, uterine fibroids can grow to be several centimeters indiameter and may cause symptoms like menorrhagia (prolonged or heavymenstrual bleeding), pelvic pressure or pain, and reproductivedysfunction.

Current treatments for uterine fibroids include pharmacological therapy,hysterectomy, uterine artery embolization, and hysteroscopic resection.Pharmacological therapy typically involves the administration of NSAIDS(non-steroidal anti-inflammatory drugs), estrogen-progesteronecombinations, and GnRH (gonadotropin releasing hormone) analogues.However, current pharmacological therapies are largely ineffective andmerely palliative. By comparison, a hysterectomy involves the surgicalremoval of the uterus from a patient. For this reason, a hysterectomyrepresents a highly effective way of ridding a patient of uterinefibroids. As a result, several hundred thousand hysterectomies aretypically performed annually in the United States to treat uterinefibroids. However, despite their widespread use, hysterectomies alsopossess certain disadvantages, such as a loss of fertility, sexualdysfunction, and the risks commonly associated with a major surgicalprocedure, such as hemorrhaging, lesions, infections, pain and prolongedrecovery. Uterine artery embolization involves inserting a catheter intoa femoral artery and then guiding the catheter to a uterine fibroidartery. Small particles are then injected from the catheter into thefibroid artery, blocking its blood supply and causing it to eventuallyshrink and die. Although this procedure is less invasive than ahysterectomy, it often results in pain-related, post-surgicalcomplications. Moreover, the physicians that are trained to performuterine artery embolization are typically interventional radiologists,as opposed to physicians trained specifically to take care ofgynecological problems, whereas the physicians trained specifically totake care of gynecological problems typically do not possess the skillto perform catheter-based uterine artery embolization.

Hysteroscopic resection typically involves inserting a hysteroscope(i.e., an imaging scope) into the uterus through the vagina, i.e.,transcervically, and then cutting away the fibroid from the uterus usinga device delivered to the fibroid by the hysteroscope. Hysteroscopicresections typically fall into one of two varieties. In one variety, anelectrocautery device in the form of a loop-shaped cutting wire isfixedly mounted on the distal end of the hysteroscope—the combination ofthe hysteroscope and the electrocautery device typically referred to asa resectoscope. The transmission of electrical current to the uteruswith a resectoscope is typically monopolar, and the circuit is completedby a conductive path to the power unit for the device through aconductive pad applied to the patient's skin. In this manner, tissue isremoved by contacting the loop with the part of the uterus wall ofinterest. Examples of such devices are disclosed, for example, in U.S.Pat. No. 5,906,615, inventor Thompson, issued May 25, 1999.

In the other variety of hysteroscopic resection, an electromechanicalcutter is inserted through a working channel in the hysteroscope. Tissueis then removed by contacting the cutter, which typically has a rotatingcutting instrument, with the part of the uterus wall of interest.Examples of the electromechanical cutter variety of hysteroscopicresection are disclosed in, for example, U.S. Pat. No. 7,226,459,inventors Cesarini et al., issued Jun. 5, 2007; U.S. Pat. No. 6,032,673,inventors Savage et al., issued March 7, 2000; U.S. Pat. No. 5,730,752,inventors Alden et al., issued Mar. 24, 1998; U.S. Patent ApplicationPublication No. US 2006/0047185 A1, inventors Shener et al., publishedMar. 2, 2006; and PCT International Publication No. WO 99/11184,published Mar. 11, 1999, all of which are incorporated herein byreference.

In both of the above-described varieties of hysteroscopic resection,prior to fibroid removal, the uterus is typically distended to create aworking space within the uterus. (Such a working space typically doesnot exist naturally in the uterus because the uterus is a flaccid organ.As such, the walls of the uterus are typically in contact with oneanother when in a relaxed state.) The conventional technique forcreating such a working space within the uterus is to administer a fluidto the uterus through the hysteroscope under sufficient pressure tocause the uterus to become distended. Examples of the fluid usedconventionally to distend the uterus include gases like carbon dioxideor, more commonly, liquids like water or certain aqueous solutions(e.g., a saline solution or a sugar-based aqueous solution). Whereresection is effected using a resectoscope, it is typically necessarythat the distending fluid not be current-conducting so that electricityis not conducted to undesired locations. However, because the distendingfluid is administered under pressure (which pressure may be as great as100 mm Hg or greater), there is a risk, especially when tissue is cut,that the distending fluid may be taken up by a blood vessel in theuterus, i.e., intravasation, which uptake may be quite harmful to thepatient. Because excess intravasation can lead to death, it is customaryto monitor the fluid uptake on a continuous basis using a scale system.

Nevertheless, despite the aforementioned risks of intravasation, withproper monitoring of fluid uptake, hysteroscopic resection is a highlyeffective and safe technique for removing uterine fibroids. However, oneshortcoming with hysteroscopic resection is that it typically requiresthat anesthesia be administered to the patient. This is becauseconventional resectoscopes typically have a diameter in excess of 7 mmand because conventional hysteroscopes of the type through whichmechanical cutter-type devices are inserted typically have a diameter ofabout 9 mm. By contrast, the cervix typically cannot be dilated to adiameter greater than about 5.5 mm without causing considerablediscomfort to the patient. As a result, due to the need for anesthesia,hysteroscopic resection is typically performed in a hospital operatingroom and, as a result, bears a large cost due to the setting and thesupport personnel required.

SUMMARY OF THE INVENTION

The present invention provides a novel method, system and device fortissue removal. The method, system and device as described above may beused, for example, to remove uterine fibroids and other abnormalgynecological tissues.

According to one aspect of the invention, there is provided a tissueremoval device, the tissue removal device comprising (a) a housing; (b)an outer tube, the outer tube being fixed to the housing and extendingdistally therefrom, the outer tube including a resection window; (c) aninner tube disposed within the outer tube, the inner tube being slidableand rotatable relative to the outer tube, the inner tube comprising adistal end; and (d) a drive mechanism for rotating the inner tuberelative to the outer tube and, at the same time, for translationallyoscillating the inner tube relative to the outer tube so that the distalend of the inner tube rotates while moving back and forth across theresection window, wherein said drive mechanism comprises a drive shaftshaped to include a double helical groove, said drive shaft beingtranslationally stationary.

There is provided in accordance with another aspect of the presentinvention, a tubular cutting element for the tissue removal device ofthe present invention. The tubular cutting element is adapted for axialreciprocal movement within an outer tubular sleeve, the cutting elementhaving an elongate tubular body having a proximal end, a distal end, anda cutting tip. The tubular body is formed in a drawing operation and thecutting tip is formed in a milling operation. The cutting tip isattached to the tubular body by soldering, brazing, welding, or otherattachment technique.

In accordance with a further aspect of the present invention, there isprovided a tubular cutting element for axial reciprocal movement withinan outer tubular sleeve. The cutting element comprises an elongatetubular body, having a proximal end, a distal end and a cutting tip. Thetubular body has a Rockwell C hardness of no more than about 40 and thecutting tip has a Rockwell C hardness of at least about 50. The cuttingtip may have a Rockwell C hardness of at least about 60, or at leastabout 70.

A coating may be provided in-between the outer tubular sleeve and theinner tubular body. The coating may be applied to either the outertubular sleeve or the inner tubular body. The coating may comprise atitanium nitride alloy. The coating may comprise a Rockwell C hardnessof at least about 50, at least about 60, or at least about 70.

Additional aspects, features and advantages of the present inventionwill be set forth in part in the description which follows. Theembodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural or processchanges may be made without departing from the scope of the invention.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope of the present invention is best definedby the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are hereby incorporated into andconstitute a part of this specification, illustrate various embodimentsof the invention and, together with the description, serve to explainthe principles of the invention. In the drawings wherein like referencenumerals represent like parts:

FIG. 1 is a partially exploded perspective view of a first embodiment ofa tissue removal system constructed according to the teachings of thepresent invention;

FIGS. 2( a) through 2(d) are various views of the tissue removal deviceshown in FIG. 1, the tissue removal device being shown in FIGS. 2( a)through 2(c) together with the distal ends of the vacuum tube and theexternal drive shaft;

FIG. 3 is a perspective view of the introducer device shown in FIG. 1;

FIGS. 4( a) and 4(b) are exploded perspective views of the introducerdevice shown in FIG. 1;

FIG. 5 is a right perspective view of the introducer device shown inFIG. 1, with the right half of the housing removed;

FIG. 6 is a longitudinal section view of the introducer device shown inFIG. 1;

FIG. 7 is an enlarged fragmentary perspective view, shown in section, ofthe introducer device shown in FIG. 1, with only the manifold, strainrelief and sheath being shown;

FIG. 8 is an enlarged distal end view of the multi-lumen sheath of theintroducer device shown in FIG. 1;

FIG. 9 is an enlarged fragmentary view of the instrument guide assemblyof the introducer device shown in FIG. 1;

FIGS. 10( a) and 10(b) are fragmentary longitudinal section views ofalternate inner tubular members that may be used in the tissue removaldevice shown in FIG. 1;

FIG. 11 is a side view of an alternate indicator sleeve that may be usedin the tissue removal device shown in FIG. 1;

FIG. 12 is a fragmentary side view, partly in section, of an alternatecombination of a tissue removal device and an introducer that may beused in the tissue removal system shown in FIG. 1;

FIGS. 13( a) and 13(b) are fragmentary side views, partly in section, ofa further alternate combination of a tissue removal device and anintroducer that may be used in the tissue removal system shown in FIG.1;

FIG. 14 is a fragmentary side view, partly in section, of an alternatetissue removal device that may be used in the tissue removal system ofFIG. 1;

FIGS. 15( a) and 15(b) are fragmentary perspective and fragmentarypartially exploded perspective views, respectively, of another alternatetissue removal device that may be used in the tissue removal system ofFIG. 1;

FIG. 16 is a fragmentary side view of another alternate tissue removaldevice that may be used in the tissue removal system of FIG. 1;

FIG. 17 is a fragmentary side view of another alternate tissue removaldevice that may be used in the tissue removal system of FIG. 1;

FIG. 18 is a fragmentary perspective view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 1;

FIG. 19 is a fragmentary perspective view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 1;

FIG. 20 is a fragmentary perspective view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 1;

FIG. 21 is a fragmentary perspective view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 1;

FIGS. 22( a) through 22(e) are various views of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 1(the vacuum housing not being shown in FIGS. 22( c) through 22(e) toreveal components positioned therewithin);

FIG. 23 is a fragmentary section view of an obturator of the presentinvention inserted into the introducer shown in FIG. 1;

FIG. 24 is a side view of an alternate combination of an obturator andan introducer constructed according to the present invention;

FIGS. 25( a) and 25(b) are unassembled side and assembled section views,respectively, of another combination of an obturator and an introducerconstructed according to the present invention;

FIGS. 26( a) through 26(c) are fragmentary perspective views of anotheralternate introducer device to the introducer device shown in FIG. 1,with the alternate introducer device being shown in partially explodedstates in FIGS. 26( b) and 26(c);

FIG. 27 is a perspective view of a second embodiment of a tissue removalsystem constructed according to the teachings of the present invention;

FIGS. 28( a) through 28(d) are bottom exploded perspective, top explodedperspective, bottom partially exploded, and fragmentary, partly insection, side views, respectively, of the morcellator assembly shown inFIG. 27;

FIGS. 29( a) and 29(b) are partially exploded top perspective andpartially exploded bottom perspective views, respectively, of the driveassembly shown in FIG. 27;

FIG. 30 is a fragmentary, partially exploded, perspective view of analternate tissue removal device that may be used in the tissue removalsystem of FIG. 27;

FIGS. 31( a) and 31(b) are fragmentary, partially exploded, perspectiveviews of another alternate tissue removal device that may be used in thetissue removal system of FIG. 27;

FIG. 32 is a fragmentary, partially exploded, perspective view ofanother alternate tissue removal device that may be used in the tissueremoval system of FIG. 27;

FIG. 33 is a fragmentary, partially exploded, perspective view ofanother alternate tissue removal device that may be used in the tissueremoval system of FIG. 27;

FIG. 34 is a fragmentary section view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 27;and

FIG. 35 is a fragmentary section view of another alternate tissueremoval device that may be used in the tissue removal system of FIG. 27.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention is described below primarily in the context ofdevices and procedures optimized for performing one or more therapeuticor diagnostic gynecological or urological procedures such as the removalof uterine fibroids or other abnormal uterine tissue. However, thedevices and related procedures of the present invention may be used in awide variety of applications throughout the body, through a variety ofaccess pathways.

For example, the devices of the present invention can be optimized foruse via open surgery, less invasive access such as laparoscopic access,or minimally invasive procedures such as via percutaneous access. Inaddition, the devices of the present invention can be configured foraccess to a therapeutic or diagnostic site via any of the body's naturalopenings to accomplish access via the ears, nose, mouth, and viatrans-rectal, urethral and vaginal approach.

In addition to the performance of one or more gynecological and urologicprocedures described in detail herein, the systems, methods, apparatusand devices of the present invention may be used to perform one or moreadditional procedures, including but not limited to access and tissuemanipulation or removal from any of a variety of organs and tissues suchas the bladder, breast, lung, stomach, bowel, esophagus, oral cavity,rectum, nasal sinus, Eustachian tubes, heart, gall bladder, spine,shoulder, knee, hip, brain, arteries, veins, and various ducts. Routesof access include but are not limited to trans-cervical;trans-vaginal-wall; trans-uteral; trans-vesicle; trans-urethral; andother routes.

Referring now to FIG. 1, there is shown a partially exploded perspectiveview of one embodiment of a tissue removal system, the tissue removalsystem being constructed according to the teachings of the presentinvention and being represented generally by reference numeral 5.

System 5 is particularly well-suited for removing uterine fibroids andother abnormal gynecological tissues. However, it should be understoodthat system 5 is not limited to such a use and may be used in otheranatomies that may be apparent to those of ordinary skill in the art.

System 5 may comprise a tissue removal device (or morcellator) 6, anintroducer device 7, a flexible hysteroscope 8, a fluid supply 9, avacuum assembly 10, and a motor drive assembly 11.

100571 Referring now to FIGS. 2( a) through 2(d), tissue removal device6 may be seen in greater detail. Device 6 may comprise complementaryleft and right housing halves 13-1 and 13-2, respectively, each of whichmay be made of a rigid polymer or other suitable material. Halves 13-1and 13-2 may be joined together, for example, with screws 15 to form anelongated hollow housing 13 comprising a rounded side wall 16, an openproximal end 17, and an open distal end 19. Housing 13 may be bent orotherwise ergonomically shaped to fit comfortably in the hand of a user.A proximal cap 18 may be mounted in proximal end 17, cap 18 being shapedto include a pair of lumens 18-1 and 18-2. Lumen 18-1 may be used toreceive, for example, an external drive shaft, and lumen 18-2 may beused to receive, for example, a vacuum tube. A distal cap 20 may bemounted in distal end 19, cap 20 being shaped to include a lumen, whichmay be used to receive, for example, a pair of coaxial cutting tubes.

A plurality of ribs 14 may be integrally formed and appropriatelypositioned along the respective interior surfaces of halves 13-1 and13-2, ribs 14 providing structural reinforcement to housing 13 and beingused to align certain of the mechanical components that are positionedwithin housing 13.

Device 6 may further comprise an internal drive shaft 21 adapted forrotation about its longitudinal axis. Shaft 21, which may be anelongated unitary structure made of a suitably rigid metal or polymer,may be shaped to include a proximal end 23 and a distal end 25. Proximalend 23 of shaft 21 may be coaxially mounted over and fixed to the distalend 27 of an external drive shaft 29, external drive shaft 29 beinginserted through a retainer 28 mounted in housing 13. In this manner,the rotation of shaft 21 may be mechanically coupled to the rotation ofshaft 29. Distal end 25 of shaft 21 may be inserted through an opening30 in an annular bushing 31, which bushing 31 may be matingly mounted ona rib 14-1 via a circumferential slot 32 provided in bushing 31.

Device 6 may further comprise a translation drive shaft 35 adapted forrotation about its longitudinal axis. Shaft 35, which may be anelongated unitary structure made of a suitably rigid metal or polymer,may be shaped to include a proximal end 37, an intermediate portion 39,and a distal end 41. Proximal end 37 of shaft 35 may be coaxiallymounted over and fixed to the distal end 25 of internal drive shaft 21.In this manner, the rotation of shaft 35 may be mechanically coupled tothe rotation of shaft 21. Intermediate portion 39 may be shaped toinclude a double helical portion comprising a right-handed threadedhelical channel 42 and a left-handed threaded helical channel 43.Helical channels 42 and 43 may have identical or different pitches butpreferably have identical pitches. Helical channels 42 and 43 may besmoothly blended together at their respective ends to form a continuousgroove so that there may be a smooth transition from one helical channelto the other. Distal end 41 of shaft 35 may be appropriately dimensionedto be received within an opening 44 in an annular bushing 45, whichbushing 45 may be matingly mounted on a rib 14-2 via a circumferentialslot 46 provided in bushing 45. It should be noted that, although shaft35 is adapted for rotation, shaft 35 is translationally stationary.

Device 6 may further comprise a gear assembly 50 adapted for rotationabout its longitudinal axis. Gear assembly 50, which may be an elongatedunitary structure made of a suitably rigid metal or polymer, may beshaped to include a proximal spur gear 51 and a distal tube portion 52.Gear assembly 50 may be coaxially mounted over intermediate portion 39of shaft 35 in an area between the double helical portion and distal end41, and gear assembly 50 may be fixed to shaft 35 using a pin insertedradially through tube portion 52 and into an opening provided in shaft35. In this manner, the rotation of spur gear 51 may be mechanicallycoupled to the rotation of shaft 35.

Device 6 may further comprise an oscillating translation assembly 61.Translation assembly 61, in turn, may comprise a carriage 62 and achannel engagement member 63. Carriage 62, which may be a unitarystructure made of a suitably rigid metal or polymer, may be shaped toinclude a proximal portion 64, an intermediate portion 65, and a distalportion 66. The tops of proximal portion 64 and distal portion 66 mayextend beyond the top of intermediate portion 65 and may be shaped toinclude loops 67-1 and 67-2, respectively, loops 67-1 and 67-2 beingaligned with one another. A longitudinal bore 68-1 may be provided nearthe bottom of carriage 62, bore 68-1 being appropriately dimensioned tocoaxially receive intermediate portion 39 of shaft 35 while permittingintermediate portion 39 to rotate freely therewithin. Channel engagementmember 63, which may be a unitary structure made of a suitably rigidmetal or polymer, may be shaped to include a base 69 and a pawl 70. Base69 may be disposed in an opening 68-2 that may extend downwardly fromthe top of intermediate portion 65 into communication with bore 68-1,with pawl 70 traveling within the double helical portion of shaft 35. Inthis manner, as shaft 35 rotates, pawl 70 may continuously travel backand forth through the double helical portion of shaft 35, therebycausing carriage 62 to oscillate translationally. As can be appreciated,the speed at which carriage 62 oscillates translationally may be varied,for example, by varying the translational length of the double helicalportion of shaft 35, the angles of channels 42 and 43, the rotationalspeed of shaft 29, etc. As will be discussed further below, it may bedesirable to operate device 6 so that carriage 62 oscillatestranslationally at about 2.8 cycles/second.

Device 6 may further comprise a shaft 72 adapted for rotation about itslongitudinal axis. Shaft 72, which may be an elongated, unitary, tubularstructure made of a suitably rigid metal or polymer, may be shaped toinclude a proximal portion 72-1 and a distal portion 72-2. Proximalportion 72-1 may be inserted through loops 67-1 and 67-2 of carriage 62and may freely rotate relative to loops 67-1 and 67-2. Distal portion72-2 may be in the form of an elongated spur gear. Distal portion 72-2may be engaged with spur gear 51 of gear assembly 50 so that therotation of spur gear 51 causes the rotation of shaft 72. Distal portion72-2 may be elongated so that it may maintain engagement with spur gear51 even as distal portion 72-2 moves translationally relative to spurgear 51. The speed at which distal portion 72-2 rotates (and, therefore,the speed at which shaft 72 rotates) may be the same as or differentthan the speed at which spur gear 51 rotates, depending, for example, onthe relative diameters of the two gears (the ratio of the rotationalspeeds of the two gears being inversely proportional to the ratio of thediameters of the two gears). Consequently, by appropriately dimensioningspur gear 51 and distal portion 72-2, one can achieve a desiredrotational speed, even where the rotational speed of the external driveshaft is fixed. For example, in the embodiment shown, distal portion72-2 has a diameter that is one-fourth the diameter of spur gear 51 and,therefore, rotates four times as fast as gear 51. Therefore, if theexternal drive shaft has a speed of rotation of about 1500 rpm, gear 51would rotate at 1500 rpm and distal portion 72-2 would rotate at 6000rpm. As can be appreciated, the rotational speed of distal portion 72-2does not depend on the interaction of translation assembly 61 with thedouble helical portion of shaft 35; consequently, distal portion 72-2may attain higher or lower rotational speeds than would be possiblebased on the requirements of a desired translational speed.Notwithstanding the above, shaft 72 is translationally coupled tocarriage 62. Consequently, as carriage 62 oscillates translationally, sodoes shaft 72.

Device 6 may further comprise a strain relief member 74, which may be aunitary tubular structure made of a rigid polymer or metal. The proximalend of strain relief member 74 may be fixedly mounted in a retainer 75,which may be mounted at the distal end of housing 13, with the distalend of strain relief 74 extending distally from housing 13 for a shortdistance, such as, for example, approximately 2 inches.

Device 6 may further comprise a cutting mechanism. In the presentembodiment, the cutting mechanism may comprise an outer tubular member76 and an inner tubular member 77, inner tubular member 77 movingrotationally and, at the same time, oscillating translationally relativeto outer tubular member 76 in the manner to be described further below.Outer tubular member 76, which may be a unitary structure made ofstainless steel or another similarly suitable material, may be shaped toinclude an open proximal end, a closed distal end 81, and a lumen 82extending from open proximal end 79 to a point just prior to closeddistal end 81. Member 76 may be coaxially mounted within strain reliefmember 74, with the proximal end of member 76 disposed within theproximal end of strain relief member 74 and with distal end 81 of member76 extending distally beyond the distal end of strain relief member 74for an extended distance, such as, for example, five inches. Theproximal end of member 76 may be fixed within retainer 75.

Outer tubular member 76 may be further shaped to include a resectionwindow 89 into which tissue may be captured and drawn, window 89 beinglocated proximate to distal end 81, such as, for example, 0.25 inch fromdistal end 81. Window 89 may be shaped to include a proximal end 89-1and a distal end 89-2. Proximal end 89-1 may slope gradually proximally,and distal end 89-2 may slope gradually distally. More specifically,window 89 may have a length of approximately 0.55 inch, proximal end89-1 may be a radial end having a radius of curvature of, for example,0.085 inch, and distal end 89-2 may be a radial end having a radius ofcurvature of, for example, 0.150 inch. Window 89 may extend over asubstantial portion of the circumference of tubular member 76, such as,for example, about 60% of the circumference.

Outer tubular member 76 may have an outer diameter less than about 5.5mm. However, in order to reduce the risk of injury to the patient and inorder to obviate the need for anesthesia to be administered to thepatient, outer tubular member 76 preferably has an outer diameter lessthan about 5 mm, more preferably less than 4 mm, even more preferablyless than 3 mm, and still even more preferably less than 2 mm. However,should device 6 be used in an operating room setting where generalanesthesia is available, the diameter of the outer tubular member 76could be increased to maximize tissue removal. In such a case, outertubular member 76 could have a diameter generally less than about 12 mm,preferably less than about 11 mm, and for certain applications less than10 mm. Depending on the particular clinical application, outer tubularmember 76 could be constructed having an outer diameter of no more thanabout 9 mm, in some applications less than about 8 mm, preferably lessthan 7 mm, and more preferably less than 6 mm where OD is desirablyminimized.

Inner tubular member 77, which may be an elongated unitary structuremade of stainless steel or another similarly suitable material, may beshaped to include a proximal end 91, a distal end 92, and a longitudinallumen 93. Distal end 92 may be shaped to include an external bevel, suchas, for example, an external bevel of approximately 20 degrees. Anintermediate length of tubular member 77 may be coaxially receivedwithin shaft 72 and may be fixedly coupled to shaft 72 for translationaland rotational movement therewith. Proximal end 91 of tubular member 77may be slideably mounted within a vacuum tube connector 95, which may,in turn, be coupled to a vacuum tube 393 inserted through lumen 18-2 ofcap 18. An O-ring 96 may be mounted within connector 95 to maintain agood seal with tubular member 77. An annular bushing 98 mounted withinhousing 13 may be used to receive tubular member 77 and to maintain itsalignment.

Tubular members 76 and 77 may be arranged so that, when tubular member77 is in a fully retracted (i.e., proximal) position, distal end 92 oftubular member 77 may be withdrawn sufficiently to permit tissue toenter window 89 (preferably with distal end 92 of tubular memberpositioned proximal to window 89), and so that, when tubular member 77is in a fully advanced (i.e., distal) position, distal end 92 of tubularmember 77 may be positioned distally of distal end 89-2 of window 89. Inthis manner, as tubular member 77 is moved translationally androtationally past window 89, tissue within window 89 may be sheared. Topromote such a shearing of tissue, the outer diameter of inner tubularmember 77 may be just slightly less (e.g., about 0.002 inch) than theinner diameter of outer tubular member 76.

It has been shown that the thermal energy created by the contact of therotating inner tube 77 and outer tube 76 can lead to galling where thetwo tubular members fuse together. To mitigate that galling risk, theouter surface of inner tube 77 has been covered with a low friction, lowabrasion coating (i.e., Titanium Nitride). Alternatively, the coatingcan be carried by the inner surface of the outer tube 76. The coatingmay have a Rockwell C hardness of at least about 50, preferably at leastabout 60 and in some devices at least about 70.

Device 6 may further comprise an indicator sleeve 98. Sleeve 98, whichmay be an elongated tubular member made of a material that is easilydistinguishable visually from strain relief member 74, may be coaxiallymounted over strain relief member 74 and fixedly mounted thereto, with aproximal end 98-1 of sleeve 98 lying flush against the distal end ofhousing 13. An example of a material suitable for use as sleeve 98 maybe a white or colored length of shrink-wrap material. Sleeve 98 may bedimensioned so that, when device 6 is inserted into introducer device 7,distal end 98-2 of sleeve 98 is visible to a user until distal end 81 ofdevice 6 is advanced beyond the distal end of introducer 7. In otherwords, distal end 98-2 may be used to indicate when distal end 81 ofdevice 6 lies flush with the distal end of introducer 7. In this manner,a user may safely control the position of the distal end of device 6and, therefore, keep it within introducer 7 when inserting device 6 intoa patient, thereby reducing the risks for lacerations and perforationsduring introduction of device 6.

Referring now to FIGS. 3 through 7, introducer 7 may comprise a housing121. Housing 121, in turn, may comprise a left handle half 123 and aright handle half 125. Left handle half 123 and right handle half 125,which may be molded or otherwise fabricated from a rigid polymer orother suitable material, may be joined by a plurality of screws 127.Instead of being joined by screws 127, left handle half 123 and righthandle half 125 may be joined using a suitable adhesive, crush pins, ormay be welded together ultrasonically or otherwise. Left handle half 123and right handle half 125 jointly define a hollow, gun-shaped structurecomprising a handle portion 129 and a barrel portion 131. Handle portion129 may be shaped to include an opening 133 provided at its bottom end134 and an opening 135 provided along its distal face 136 near bottomend 134. A slot 133-1 may be provided in right handle half 125, slot133-1 extending from opening 133 towards barrel portion 131 for a shortdistance. Barrel portion 131 may be shaped to include an opening 137provided at its proximal end 138 and an opening 139 provided at itsdistal end 140. In addition, barrel portion 131 may be shaped to includea transverse opening 141 provided in right handle half 125 at a locationintermediate to proximal end 138 and distal end 140.

The interior surfaces of left handle half 123 and right handle half 125may shaped to include complementary sets of ribs (not shown). Such ribsmay provide structural reinforcement to left handle half 123 and righthandle half 125 and may help to maintain the correct positioning andalignment of the components positioned within housing 121.

Introducer 7 may further comprise a manifold 145. Manifold 145, whichmay be molded or otherwise fabricated from a rigid polymer or othersuitable material, may be a unitary, branched structure shaped toinclude a main tubular member 147 and a side tubular member 149. Mainmember 147 may comprise a proximal end 151, an open distal end 153, aside wall 155, and a longitudinal lumen 157. Proximal end 151 of mainmember 147 may be shaped to include a top opening 159 of comparativelygreater diameter and a bottom opening 161 of comparatively smallerdiameter. Side member 149 may comprise an open proximal end 163, an opendistal end 165, a side wall 167, and a longitudinal lumen 169. Lumen 169of side member 149 may be in fluid communication with lumen 157 of mainmember 147 through open distal end 165.

Manifold 145 may be coupled to housing 121 using a pair of pins 171 and173 that may extend from side wall 155 and that may be received withinhollow embossments 175 and 177, respectively, provided on the interiorfaces of left handle half 123 and right handle half 125, respectively.With manifold 145 thus coupled to housing 121, proximal end 151 ofmanifold 145 may be positioned in barrel portion 131, with side wall 155tightly fitting within opening 139 and with distal end 153 of manifold145 extending distally a short distance beyond distal end 140.

Introducer 7 may further comprise a strain relief member 181. Strainrelief member 181, which may be molded or otherwise fabricated from arigid polymer or other suitable material, may be a unitary tubularstructure shaped to include an open proximal end 183, an open distal end185, a side wall 187, and a longitudinal lumen 189. Strain relief member181 may be partially inserted into lumen 157 of manifold 145 and may betightly fitted within lumen 157 and fixedly secured thereto using asuitable adhesive or the like, with proximal end 183 of strain reliefmember 181 being positioned just distal to open distal end 165 of sidemember 149 and with distal end 185 of strain relief member 181 extendingdistally a short distance beyond distal end 153 of main member 147.

Introducer 7 may further comprise a sheath 191, which is also shownseparately in FIG. 8. Sheath 191, which may be extruded or otherwisefabricated from a suitable polymer, such as nylon 12, may be a rigid,unitary structure shaped to include a proximal end 192, a distal end193, and a side wall 194. Sheath 191 may be further shaped to include aplurality of longitudinal lumens of fixed shape and size, such lumensincluding a top lumen 196, a bottom lumen 197, and a pair of side lumens198-1 and 198-2. As will be discussed further below, top lumen 196 maybe used as an instrument lumen, bottom lumen 197 may be used as avisualization lumen, and side lumens 198-1 and 198-2 may be used asinflow fluid supply lumens. (Openings (not shown) may be provided inside wall 194 proximate to distal end 193, such side openings fluidlycommunicating with side lumens 198-1 and 198-2, for example, to dispensesome of the inflow fluid supply conducted distally through side lumens198-1 and 198-2.) Proximal end 192 of sheath 191 may be partiallyinserted into lumen 189 of strain relief member 181 and may be tightlyfitted within lumen 189 and fixedly secured thereto using a suitableadhesive or the like, with proximal end 192 of sheath 191 flush withproximal end 183 of strain relief member 181 and with distal end 193 ofsheath 191 extending distally beyond distal end 185 of strain reliefmember 181 for several inches.

Sheath 191, which is preferably the only component of introducer 7 thatis to be inserted into a patient, may be dimensioned to have an outerdiameter of about 5.5 mm, with lumen 196 having a diameter of about 3mm, lumen 197 having a diameter of about 2 mm, and lumens 198-1 and198-2 each having a diameter of about 1.33 mm. It can be further statedthe ratio of the outer diameter to the working channel is an exemplarymetric of introducer efficiency. It can be seen that the optimal ratiowould be about 1.0, preferably no more than about 2.1 and morepreferably no more than about 1.9. In the case provided herein, theratio of these diameters is about 1.83 while predicate systems haveratios of 2.25. By thus dimensioning sheath 191, if sheath 191 isinserted through the cervix of a patient, the risk of injury to thepatient and the need for anesthesia to be administered to the patientmay be minimized. However, it should be understood that the abovedimensions for sheath 191 are merely exemplary and may be varieddepending upon how introducer 7 is to be used.

Introducer 7 may further comprise an instrument guide assembly mountedwithin housing 121 for providing a continuous channel aligned with lumen196 into which tissue removal device 6 may be inserted. The instrumentguide assembly may comprise a guide body 201. Body 201, which may bemolded or otherwise fabricated from a rigid polymer or other suitablematerial, may be a unitary tubular structure shaped to include aproximal portion 203, a distal portion 205 and an intermediate portion207. Intermediate portion 207 may be reduced in inner diameter and inouter diameter relative to proximal portion 203 and distal portion 205so that an annular seat 208 is formed within body 201 at the juncture ofintermediate portion 207 and distal portion 205. The interior surface ofbody 201 may taper inwardly from proximal portion 203 to intermediateportion 207 to facilitate insertion of device 6 into intermediateportion 207 and to delimit the extent to which device 6 may be insertedinto body 201.

Body 201 may be tightly fitted within opening 137 of housing 121 andfixedly secured thereto using a suitable adhesive or the like, withdistal portion 205 and intermediate portion 207 of body 201 beingpositioned within barrel portion 131 of housing 121 and with proximalportion 203 of body 201 extending through opening 137 and continuingproximally for a short distance beyond proximal end 138 of housing 121.

The instrument guide assembly may further comprise a sleeve 211. Sleeve211, which may be molded or otherwise fabricated from a rigid polymer orother suitable material, may be a unitary, branched structure shaped toinclude a main tubular member 213 and a side tubular member 215. Mainmember 213 may comprise an open proximal end 216, an open distal end217, and a longitudinal lumen 219. Proximal end 216 of main member 213may be shaped to be tightly fitted within distal portion 205 of body 201and may be bonded thereto using a suitable adhesive. Side member 215 maycomprise an open proximal end 220, an open distal end 221 and alongitudinal lumen 223. Lumen 223 of side member 215 may be in fluidcommunication with lumen 219 of main member 213 through open proximalend 220. Distal end 221 of side member 215 may extend through opening141 provided in right handle half 125 of housing 121 and may be coupledto a valve 228. Valve 228 may be an actively-controlled valve, such as astopcock valve, or a passively-controlled valve, such as aspring-activated ball valve. Valve 228 may be connected at its outputend to a length of tubing (not shown), as well as to a fluid receptacle(not shown), for conducting, as well as collecting, for example, outflowfluid passing through valve 228, for example, when device 6 is notpresent within introducer 7.

The instrument guide assembly may further comprise the combination of aseal 231 and a valve 233. Seal 231 and valve 233 may be elastomericmembers securely positioned between seat 208 of body 201 and proximalend 216 of sleeve 211 (see FIG. 9). Seal 231, which may be locatedproximally relative to valve 233, may include a central opening 235.Opening 235 may be appropriately dimensioned so that, when device 6 isinserted therethrough, fluid may not readily pass proximally throughseal 231 around the outside of device 6. Valve 233, which may be shapedto include a dome having a cross-slit at its top, may be designed sothat, in the absence of device 6 being inserted therethrough, fluid maynot readily pass proximally therethrough.

The instrument guide assembly may further comprise a tube 241. Tube 241,which may be a rigid hypotube made of stainless steel or the like, maycomprise a proximal end 243 and a distal end 245. Proximal end 243 maybe fixedly mounted within lumen 219 of sleeve 211 using a suitableadhesive or the like. Distal end 245 of tube 241 may be tightly fittedwithin lumen 196 of sheath 191 and may be secured therewithin using asuitable adhesive or the like.

Introducer 7 may further comprise a visualization guide assembly mountedwithin housing 121 for providing a continuous channel aligned with lumen197 into which hysteroscope 8 may be inserted. The visualization guideassembly may comprise a guide body 251. Body 251, which may be molded orotherwise fabricated from a rigid polymer or other suitable material,may be a unitary tubular structure shaped to include a proximal portion253 of comparatively greater diameter, a distal portion 255 ofcomparatively smaller diameter, and an intermediate portion 257 taperingin diameter from proximal portion 253 to distal portion 255. Body 251may be disposed within handle portion 129 of housing 121, with proximalportion 253 spaced inwardly a short distance from opening 133 and withdistal portion 255 facing towards barrel portion 131. Proximal portion253 may be tightly fitted between and fixedly secured to left handlehalf 123 and right handle half 125 of housing 121 using adhesive orother suitable means. As will be discussed further below, proximalportion 253 may be appropriately dimensioned to receive the proximalportion of hysteroscope 8, with intermediate portion 257 of body 251being appropriately dimensioned to serve as a stop to limit the extentto which hysteroscope 8 may be inserted into body 251. An annular seat258 may be provided within distal portion 255 and may be spacedproximally relative to distal end 259 of distal portion 255.

The visualization guide assembly may further comprise a guide connector261. Guide connector 261, which may be molded or otherwise fabricatedfrom a rigid polymer or other suitable material, may be a unitarytubular structure shaped to include a proximal portion 263 ofcomparatively greater diameter, a distal portion 265 of comparativelysmaller diameter, and an intermediate portion 267 tapering in diameterfrom proximal portion 263 to distal portion 265. Proximal portion 263may be shaped to be tightly fitted within distal portion 255 of body 251and may be bonded thereto using a suitable adhesive.

The visualization guide assembly may further comprise the combination ofa seal 271 and a valve 273. Seal 271 and valve 273 may be elastomericmembers securely positioned between seat 258 of body 251 and proximalportion 263 of connector 261. Seal 271, which may be located proximallyrelative to valve 273, may include a central opening appropriatelydimensioned so that, when hysteroscope 8 is inserted therethrough, fluidmay not readily pass proximally through seal 271 around the outside ofhysteroscope 8. Valve 273, which may be shaped to include a dome havinga cross-slit at its top, may be designed so that, in the absence ofhysteroscope 8 being inserted therethrough, fluid may not readily passproximally therethrough.

The visualization guide assembly may further comprise a tube 281. Tube281, which may be a flexible unitary member fabricated from a suitablepolymer or other material, may comprise a proximal end 283, a distal end285, and a lumen 286. Proximal end 283 may be fixedly mounted withindistal portion 265 of connector 261 using a suitable adhesive or thelike. Distal end 285 of tube 281 may be tightly fitted within lumen 197of sheath 191 and may be secured therewithin using a suitable adhesiveor the like. Lumen 286 may be appropriately dimensioned so that thedistal portion of hysteroscope 8 may be inserted thereinto and, in thismanner, guided by tube 281 to lumen 197.

Introducer 7 may further comprise a mechanism for reversibly couplinghysteroscope 8 to the visualization guide assembly. This mechanism maycomprise a cam lock 291. Lock 291, which may be fabricated from a rigidpolymer or other suitable material, may be a unitary structure shaped tocomprise a lever 292 and a fulcrum 293. The fulcrum 293 may be pivotallymounted on housing 121 using a pivot pin 294 inserted through atransverse opening 295 in fulcrum 293 and securely received at itsopposite ends in openings 296 and 297 provided in left handle half 123and right handle half 125, respectively. Fulcrum 293 may comprise a face298 adapted to frictionally engage the proximal portion of hysteroscope8 when lever 292 is pivoted towards handle portion 129.

Introducer 7 may further comprise a tube 301. Tube 301, which may befabricated from a suitable polymer or other material, may be a flexibleunitary structure shaped to include a proximal end 303 and a distal end305. Proximal end 303 may be secured to the distal end of a luer fitting307 securely mounted within opening 135 of housing 121. Distal end 305may be positioned within lumen 169 of manifold 145 and may be secured inplace using an adhesive or other suitable means. As will be discussedfurther below, luer fitting 307 may be connected to the output of fluidsupply 9. In this manner, fluid dispensed through fitting 307 and intotube 301 may be conducted by tube 301 to manifold 145. Thereafter, thefluid in manifold 145 may flow distally through lumens 198-1 and 198-2of sheath 191.

Referring back now to FIG. 1, hysteroscope 8, which may be, for example,a conventional flexible hysteroscope, may comprise a proximal portion311 and a distal portion 313. Proximal portion 311, which may becomparatively rigid, compact in length, and wide in diameter, maycomprise an input port 315, an output port 317, and a distal end 318.Distal portion 313, which may be comparatively flexible, elongated inlength, and narrow in diameter, may comprise a distal end 319.Hysteroscope 8 may be appropriately dimensioned so that distal end 318of proximal portion 311 may be received in body 251, with distal portion313 extending distally through seal 271, valve 273, connector 261, tube281 and lumen 197 and with distal end 319 positioned at or a shortdistance beyond distal end 193 of sheath 191. Although not present inthe embodiment shown, proximal portion 311 of hysteroscope 8 may beprovided with notches or other physical features that may be used tomate with or otherwise engage cam lock 291. Distal end 319 ofhysteroscope 8 may be constructed to permit the viewing of objects, suchas at 0, 15 or 30 degree angles, relative to the longitudinal axis ofdistal portion 313. In this manner, by placing hysteroscope 8 in aparticular angular orientation, hysteroscope 8 may be used to view theoperation of the distal end of device 6. Such an angular orientation maybe ensured by orienting hysteroscope 8 so that input port 315 is alignedwith and extends through slot 133-1.

Fluid supply 9 may comprise a fluid-containing syringe, a peristalticpump or another suitable fluid-dispensing device having an output end321 that may be coupled to luer fitting 307. Fluid supply 9 may compriseautomated means (not shown) for dispensing inflow fluid therefrom at adesired rate.

Vacuum assembly 10 may include a specimen collection container 391 and avacuum source 392. The distal end of an evacuation tube 393 may beconnected to the proximal end of vacuum tube connector 95, and theproximal end of evacuation tube 393 may be coupled to a first port 394of container 391. The distal end of a tube 395 may be coupled to asecond port 396 of container 391, and the proximal end of tube 395 maybe coupled to vacuum source 392. In this manner, vacuum source 392 maybe used to apply suction to device 6, and any withdrawn tissue, liquidsor similar matter suctioned through device 6 may be collected incontainer 391.

Motor drive assembly 11, which may be coupled to a source ofelectricity, such as an AC wall outlet, using a power cord (not shown),may include a housing 397, in which there may be disposed electronics(not shown) and a motor (not shown). A foot pedal 398 may be coupled tothe motor drive assembly by a cable 398-1 and may be used as a powerswitch to selectively activate or de-activate the motor. The proximalend of shaft 29 may be mechanically coupled for rotation to the motor,and the distal end of shaft 29 may be inserted through opening 18-1 inmounting block 18 and coupled to internal shaft 21 in the mannerdiscussed above. A protective sheath 399 may cover much of the length ofshaft 29. Motor drive assembly 11 may further include a vacuum sensor400, which may be coupled to container 391 by a tube 401, so that thepressure within container 391 may be monitored. In this manner, a suddenincrease in vacuum pressure may indicate that a clog has occurred. Thepresence of a clog may be indicated via an alarm (not shown) located onhousing 397. The detection of a clog is often a clear indication thatthe further operation of device 6 may only aggravate the cloggingsituation and that a cessation of tissue removal may be necessary. Motordrive assembly 11 may be configured to synchronize actuation of themotor with actuation of vacuum source 392. In this manner, turning onthe motor will turn on vacuum source 392 at the same time.Correspondingly, vacuum source 392 may be deactivated whenever the motoris turned off.

In use, distal end 319 of hysteroscope 8 may be inserted first throughthe visualization guide channel of introducer 7, next through manifold145, and then through lumen 197 of sheath 191. With hysteroscope 8 thusinserted into introducer 7, cam lock 291 may be used to secure proximalportion 311 of hysteroscope 8 to introducer 7. Input end 315 and outputend 317 of hysteroscope 8 may then be coupled to a light source and to acamera, respectively. Alternatively, the camera may be omitted, andoutput end 317 may be observed directly with the unaided eye. Fluidsupply 9 may then be coupled to luer fitting 307 of introducer 7. Distalend 193 of sheath 191 may then be inserted transcervically, i.e.,through the vagina and the cervix, into the uterus of the patient. Priorto introducing distal end 193 of sheath 191 into the patient, the cervixmay be gradually dilated in the conventional manner using obturators ofincreasing diameter. The uterus may then be washed of blood and otherdebris that may be present by dispensing fluid from fluid supply 9 intointroducer 7, which fluid may then exit introducer 7 distally throughlumens 198-1 and 198-2. Valve 228 may be opened during this washingprocedure so that fluid and any debris present in the uterus may exitthe uterus proximally through lumen 196 of sheath 191 and, thereafter,may exit introducer 7 by passing proximally through tube 241, into mainmember 213 of sleeve 211, through side member 215 of sleeve 211, andthrough valve 228. When the washing procedure is complete, valve 228 maybe closed while fluid may continue to be dispensed into the uterusthrough lumens 198-1 and 198-2, thereby causing the uterus to becomedistended by the fluid. When the uterus becomes sufficiently distendedby such fluid, valve 228 may be opened while fluid may continue to bedispensed into the uterus. In this manner, the uterus may be maintainedat a desired degree of distension while fluid is continuously circulatedthrough the uterus. With the uterus thus distended with fluid,hysteroscope 8 may be used to examine the interior of the uterus.

If abnormalities are detected that one wishes to remove, tissue removaldevice 6 may be loaded into introducer 7, i.e., by inserting the distalends of outer tubular member 76 and inner tubular member 77 distallythrough the instrument channel guide of introducer 7 and then throughchannel 196 of sheath 191, with housing 13 remaining external to thepatient. Device 6 may then be manipulated so that window 89 of outertubular member 76 may be positioned in proximity to the fibroid or othertargeted tissue. Next, vacuum source 392 may be operated so as to causesuction to be applied to inner tubular member 77, thereby drawing tissueinto outer tubular member 76 through window 89. In addition, the motorof motor drive assembly 11 may be actuated, thereby causing innertubular member 77 simultaneously to rotate and to oscillate back andforth translationally within outer tubular member 76, resulting in thetissue drawn through window 89 to be cut. The cut tissue may then besuctioned from the patient through inner tubular member 77 by means ofthe aforementioned suction and, thereafter, collected in container 391.Once the fibroids or other targeted tissues have thus been removed fromthe patient, vacuum source 392 and the motor may be turned off, device 6may be withdrawn from introducer 7, and introducer 7 may be withdrawnfrom the patient. Device 6 may be designed to be a single use device. Ifso, device 6 may then be disconnected from evacuation tube 393 andflexible motor shaft 398-2 and disposed of properly.

It should be noted that, although the above-discussion contemplatesusing introducer 7 to introduce device 6 into the uterus, one may insertdevice 6 transcervically into the uterus without the use of introducer7. In such a situation, fluid may be administered transcervically to theuterus by a fluid dispensing device in order to distend the uterus, and,thereafter, observation of the uterus may be accomplished, for example,by ultrasonic imaging using an ultrasonic probe inserted transcervicallyinto the uterus. Such an ultrasonic probe may be separate from device 6or may be integrated into device 6. Alternatively, imaging of the uterusmay be performed by MRI imaging.

Although one may vary one or more of the speed of rotational movement ofinner tubular member 77, the frequency of oscillating translationalmovement of inner tubular member 77, the advance ratio of inner tubularmember 77 (i.e., the ratio of the speed at which tubular member 77oscillates translationally to the speed at which tubular member 77rotates), and the magnitude of suction provided by vacuum source 392,particularly good results have been achieved under the followingconditions: speed of rotation of tubular member 77—at least 1100 rpm,more preferably at least 5000 rpm, even more preferably approximately6000 rpm; frequency of oscillating translational movement of tubularmember 77—at least 1.5 cycles/second, more preferably about 2.5 to 4cycles/second, even more preferably about 2.8 cycles/second; advanceratio of preferably less than 0.25, more preferably less than 0.15; andvacuum pressures in the range of 200 to 650 mmHg. Preferably, the aboveparameters are selected to achieve a rate of tissue removal of at least1.5 gm/min while outer tubular member 76 has an outer diameter of nogreater than about 3.0 mm.

As can be appreciated, as suction is applied to inner tubular member 77,some of the distension fluid located in the uterus may incidentally bewithdrawn from the uterus through inner tubular member 77. This loss ofdistension fluid from the uterus may be undesirable if it interfereswith maintenance of the uterus in an adequately distended state.Preferably, system 5 is constructed and operated so that, with a vacuumin excess of 300 mmHg, a volume of no more than about 300 cc/min offluid is removed. This may involve, for example, applying suction onlyat specific times, for example, only when the motor for moving innertubular member 77 is actuated or by closing resection window 89 withinner tubular member 77 each time the motor control is stopped.

In general, morcellators may be built in accordance with the presentinvention to have a lower outside diameter or crossing profile thancurrent commercial products such as the Smith & Nephew HysteroscopicMorcellator, but at the same time accomplish a higher tissue resectionrate. In addition, morcellators in accordance with the present inventionmay be operated at a significantly higher vacuum while managing totalfluid flow within acceptable limits.

For example, the cross sectional area of the aspiration lumen inmorcellators in accordance with the present invention will typically beno more than about 12.0 square millimeters, and often no more than about10.0 square millimeters. In certain embodiments, a cross sectional areaof the aspiration lumen will be no more than about 8.0 millimeterssquared, and, for certain applications, the area will be no more thanabout 7.5 square millimeters.

The tissue resection rate is generally at least about 1.5 gm/min, andoften at least about 1.8 gm/min. In certain embodiments, the tissueresection rate is at least about 2.0 gm/min, and, in one embodiment, 2.2or more gm/min.

Morcellators in accordance with the present invention may be constructedto have a fluid usage of no more than about 350 ml/min. In certainembodiments, fluid usage of no more than about 300 ml/min or no morethan about 275 ml/min may be constructed.

Applied vacuum to the morcellators of the present invention willgenerally be in the range of from about 200 to about 650 mm Hg. Themorcellator will typically be run at a vacuum of at least about 350 mmHg, and, often at least about 500 mm Hg.

In one embodiment of the present invention, the cross sectional area ofthe aspiration lumen was about 7.1 mm², and yielded a tissue resectionrate of about 1.4 gm/min, under vacuum of approximately 600 mm Hg.

In general, procedures accomplished in accordance with the presentinvention will require no more than about 10 minutes, and preferably, nomore than about 8 or 9 minutes of active morcellation. During that time,total fluid (e.g. saline) introduced into the uterus will generally beno greater than about 12 liters, and, preferably no greater than about10 liters or 8 liters. Distension fluid will preferably be maintained ata low enough pressure and short enough time to keep the total salineintravasation below 2.5 liters.

In a typical procedure in accordance with the present invention,utilizing a morcellator having an outside diameter of 3 mm, the fluidflow rate for aspiration of saline through the morcellator isapproximately 260 ml/min (e.g. within the range of from about 240 toabout 280 ml/min). Thus, in a ten minute procedure, approximately 2.6liters of saline is aspirated through the morcellator. In that sameprocedure, the tissue resection rate is typically in excess of about 2gm/min.

In a comparative experiment, a device manufactured in accordance withthe present invention was compared to the performance of a reciprocatinghysteroscopic morcellator from Smith and Nephew. Over a series ofexperiments with the predicate device, the vacuum was maintained onaverage in the 200 to 270 mm Hg range, morcellator speed wasapproximately 1100 rpm, tissue resection rate was approximately 1.4gm/min, the fluid flow rate through the morcellator was approximately247 ml/min, and the outside diameter of the morcellator was 4.0 mm.

The device constructed in accordance with the present invention wasoperated at a vacuum of 600 mm Hg, a speed of about 6000 rpm, to producea resection rate of approximately 2.2 gm/min and an aspiration flow rateof about 266 ml/min through the morcellator. The outside diameter of thedevice was 3 mm.

The morcellator in accordance with the present invention thus produced asignificantly higher resection rate, through a smaller outside diametermorcellator, at a roughly comparable flow rate of aspirated saline. Inorder to increase the resection rate of the predicate device, the vacuummust be significantly increased. For example, when the vacuum pressurein the predicate system was increased to about 670 mm Hg, the tissuecutting improved to 3.5 gm/min but fluid flow rate jumped to 540 ml/min.

One challenge with increased fluid flow rate which is responsive toincreased vacuum is that the replacement fluid must be infused into theprocedure site at an equal rate. In order to infuse fluid at asufficient rate to allow the predicate device to function at a highervacuum, the diameter of the already larger predicate morcellator must beincreased. Applicants have determined that the use of the morcellatordisclosed herein, with an outside diameter of no more than about 3 mm,in combination with the optic system, allows the dilatation of thecervix be limited to no more than about 5.5 mm. Increasing the diameterof the morcellator to accommodate the higher infusion rate as well asthe already larger outside diameter of the predicate system is believedto cross the pain threshold and appears to impose the need ordesirability for conducting the procedure under a general anesthetic.Applicants believe it to be a significant benefit for many patients tobe able to avoid general anesthesia.

Referring now to FIGS. 10( a) and 10(b), there are shown fragmentarylongitudinal section views of certain alternate inner tubular membersthat may be used in tissue removal device 6. A first such alternateinner tubular member is shown in FIG. 10( a) and is representedgenerally by reference numeral 411. Inner tubular member 411 may besimilar in certain respects to inner tubular member 77; however, onenotable difference between the two tubular members is that, whereasinner tubular member 77 may be a unitary structure made from a singlepiece of material, inner tubular member 411 may be formed by joiningtogether two separate pieces of material. More specifically, innertubular member 411 may comprise a first piece in the form of a proximalstem 413 and a second piece in the form of a distal tip 415, with distaltip 415 preferably having a length greater than the length of resectionwindow 89 and more preferably having a length of less than about 2inches and in one construction, about 1 inch. Proximal stem 413 anddistal tip 415 may be made of the same material or may be made ofdifferent materials. Comparatively hard stainless steel materials, suchas 400-series stainless steels (e.g., 440C stainless steel) wherehardness exceeds Rockwell C values of about 50, are preferred for distaltip 415 as these materials enable a much sharper edge to distal tip 415to be created. On the other hand, less hard stainless steel materials,such as 300-series stainless steels (e.g., 304 stainless steel), may bepreferred for proximal stem 413 as these materials may be comparativelyinexpensively formed into long tubular structures, for example, byextrusion whereas harder stainless steel materials must be machined toform tubular structures. The Rockwell C hardness of these proximal tubematerials is less than about 40. Proximal stem 413 and distal tip 415may be joined together by welding or other suitable techniques. Any of avariety of cutter edge and window configurations may be used, dependingupon the desired performance, including any of those disclosed in U.S.patent application Ser. No. 12/098,250, filed Apr. 4, 2008 to Gruber, etal., the disclosure of which is hereby incorporated by reference in itsentirety herein.

Another notable difference between tubular member 411 and tubular member77 is that, whereas tubular member 77 may have a uniform inner diameterover its length, the inner diameter of distal tip 415 may be reduced ascompared to the inner diameter of proximal stem 413 (e.g., 0.082 inchvs. 0.085 inch). Applicants believe that this increase in inner diameterfrom distal tip 415 to proximal stem 413 may result in a reduction inthe incidence of clogging in tubular member 411 as the cut specimen,which has an outer diameter similar to distal tip 415, moves from distaltip 415 into proximal stem 413, which has a greater diameter than thecut specimen. This clearance within proximal stem 413 facilitates theproximal movement of the specimen through tubular member 411.

A second alternate inner tubular member is shown in FIG. 10( b) and isrepresented generally by reference numeral 421. Tubular member 421 maybe similar in certain respects to tubular member 411, the principaldifference between the two tubular members being that tubular member 421may be a unitary structure made from a single piece of material, whichmay be, for example, a 17-7-series stainless steel. To form tubularmember 421 from a tubular structure having a uniform inner diameter, onemay first swage or roll the distal end of the tubular structure toreduce the inner diameter of the distal end and then may increase theinner diameter of the remainder of the structure by mechanically honing,expanding, or chemically etching.

Referring now to FIG. 11, there is shown a side view of an alternateindicator sleeve 431 that may be used in tissue removal device 6.Indicator sleeve 431 may be similar in most respects to indicator sleeve98, the principal difference between the two indicator sleeves beingthat sleeve 431 may be provided with labeled or unlabeled gradations 433along its length to indicate the distance between each gradation and adistal end 431-1 of sleeve 431. Because sleeve 431 is preferablydimensioned and positioned so that distal end 431-1 of sleeve 431indicates when distal end 92 of device 6 is aligned with the distal endof introducer 7, gradations 433 indicate the relative distance betweendistal end 92 of device 6 and the distal end of introducer 7. Gradations433 may comprise, for example, numerical markings, symbols, hash marks,rings, or the like.

Referring now to FIG. 12, there is shown a fragmentary side view, partlyin section, of an alternate combination of a tissue removal device andan introducer that may be used in tissue removal system 5, the subjecttissue removal device being represented generally by reference numeral441 and the subject introducer being represented generally by referencenumeral 443.

Device 441 and introducer 443 may be similar in most respects to device6 and introducer 7, respectively, the principal differences being thatdevice 441 may include, instead of sleeve 98, a position indicator ring445 fixedly mounted on strain relief member 74, and introducer 443 mayinclude, instead of proximal portion 203 of body 201, a proximal portion447 appropriately shaped to provide just enough interference with bumps445-1 and 445-2 on ring 445 so that a user may be given a tactileindication that ring 445 is being inserted into proximal portion 447.

Referring now to FIGS. 13( a) and 13(b), there are shown fragmentaryside views, partly in section, of another alternate combination of atissue removal device and an introducer that may be used in tissueremoval system 5, the subject tissue removal device being representedgenerally by reference numeral 451 and the subject introducer beingrepresented generally by reference numeral 453.

Device 451 may be identical to device 441. Introducer 453 may be similarin most respects to introducer 7, the principal difference between thetwo introducers being that introducer 453 may be shaped to include asound chamber 455 and may additionally include a spring clip or band457. Clip 457 may have a fixed end 457-1 that is mounted within soundchamber 455 and a free end 457-2 that is constructed so as to bedeflected by ring 445 when ring 445 is moved distally past clip 457. Thedeflection of clip 457 by ring 445 causes clip 457 to oscillate and togenerate an audible signal.

Referring now to FIG. 14, there is shown a fragmentary side view, partlyin section, of an alternate tissue removal device that may be used intissue removal system 5, said tissue removal device being representedgenerally by reference numeral 470. Certain aspects of device 470 notimportant to an understanding of the invention are neither shown nordescribed herein.

Device 470 may be similar in most respects to device 6, the principaldifferences between the two devices being that, whereas device 6 maycomprise a rotational mechanism comprising a spur gear 51 engaged with agear-shaped distal portion 72-2 of a shaft 72, device 470 instead maycomprise a rotational mechanism comprising a shaft 472 comprising atubular elastomeric distal portion 472-2 engaged for rotation with anelastomeric O-ring 474 fixedly mounted within a groove 476 of acylindrical member 478 fixedly coupled to translation drive shaft 35.

Referring now to FIGS. 15( a) and 15(b), there are shown fragmentaryperspective and exploded perspective views, respectively, of anotheralternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 500. Certain aspects of device 500 not important to anunderstanding of the invention are neither shown nor described herein.

Device 500 may be similar in many respects to device 6, one differencebetween the respective tissue removal devices being that device 500 maycomprise a mounting bracket 501. Bracket 501, which may be a unitarystructure made of a rigid metal or polymer, may be shaped to include abase portion 503, a proximal block 505 extending upwardly from theproximal end of base portion 503, a distal block 507 extending upwardlyfrom the distal end of base portion 503, and an intermediate block 509extending upwardly from an intermediate portion of base portion 503.

Another difference between device 500 and device 6 is that, whereasdevice 6 may comprise an internal drive shaft 21, a translation driveshaft 35, and a gear assembly 50, device 500 may instead comprise aninternal drive shaft 510, a translation drive shaft 511, and a gearassembly 512. Internal drive shaft 510, which may be an elongatedunitary structure made of a suitably rigid metal or polymer, may beshaped to include a proximal end 513 and a distal end 515. Proximal end513 of shaft 510 may be coaxially mounted over and fixed to the distalend of external drive shaft 29. In this manner, the rotation of shaft510 may be mechanically coupled to the rotation of shaft 29. Anintermediate portion of shaft 510 may be received within a longitudinalbore 520 provided in block 505 of bracket 501. Gear assembly 512 may befixedly mounted on distal end 515 of shaft 510 so as to rotate withshaft 510. Gear assembly 512 may include a larger diameter proximal spurgear 523 and a smaller diameter distal spur gear 525. Translation driveshaft 511, which may be an elongated unitary structure made of asuitably rigid metal or polymer, may be shaped to include a proximal end537, an intermediate portion 539, and a distal end 541. Proximal end 537of shaft 511 may be in the shape of a spur gear, which may be engagedwith distal gear 525. In this manner, the rotation of shaft 511 may bemechanically coupled to the rotation of shaft 510, with the speed ofrotation of shaft 511 being dependent on the speed of rotation of shaft510 and the relative sizes of gear 525 and proximal end 537.Intermediate portion 539 may extend through a longitudinal bore 509-1provided in block 509 of bracket 501. Intermediate portion 539 may beshaped to include a double helical portion 540 similar to the doublehelical portion of shaft 35. Distal end 541 of shaft 511 may beappropriately dimensioned to be received within an opening 544 providedin block 507 of bracket 501. It should be noted that, although shaft 511is adapted for rotation, shaft 511 is translationally stationary.

Another difference between device 500 and device 6 is that, whereasdevice 6 may comprise a shaft 72 mechanically coupled to inner tubularmember 77 so as to rotate and to oscillate translationally therewith,device 500 may instead comprise an elongated shaft 551 mechanicallycoupled to inner tubular member 77 so as to rotate and to oscillatetranslationally therewith. Shaft 551, which may be a unitary tubularstructure made of a rigid metal or polymer, may be shaped to include aspur gear engaged with proximal gear 523. The gear may be elongated sothat it may maintain engagement with proximal gear 523 even as the gearmoves translationally relative to proximal gear 523. The speed at whichshaft 551 rotates may be the same as or different than the speed atwhich gear 523 rotates, depending, for example, on the relativediameters of the two gears (the ratio of the rotational speeds of thetwo gears being inversely proportional to the ratio of the diameters ofthe two gears). Consequently, by appropriately dimensioning the gears,one can achieve a desired rotational speed, even where the rotationalspeed of the external drive shaft is fixed. For example, in theembodiment shown, the gear of shaft 551 may have a diameter that isone-third the diameter of gear 523 and, therefore, rotates three timesas fast as gear 523. At the same time, proximal end 537 of shaft 511 mayhave a diameter that is four-thirds the diameter of gear 525 and,therefore, rotates three-quarters as fast as gear 525. Therefore, if theexternal drive shaft has a speed of rotation of about 2000 rpm, shaft551 (and inner tubular member 77) would rotate at about 6000 rpm andshaft 511 would rotate at about 1500 rpm, which, with an appropriateshaping of the double helix portion of shaft 511, could be used toachieve an oscillating translational speed for inner tubular member 77of about 2.8 cycles/second.

Referring now to FIG. 16, there is shown a fragmentary side view of analternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 570. Certain aspects of device 570 not important to anunderstanding of the invention are neither shown nor described herein.

Device 570 may be similar in many respects to device 6. One differencebetween the two devices may be that, whereas device 6 may fix innerdrive shaft 21 to external drive shaft 29 for rotation therewith and maycouple the rotation of inner tubular member 77 to inner drive shaft 21through the engagement of shaft 72 and gear 51, device 570 may insteadfix inner tubular member 77 to external drive shaft 29 for rotationtherewith and may couple the rotation of inner drive shaft 21 to innertubular member 77 through the engagement of a pair of spur gears 572 and574. Gear 572 may be coaxially inserted over and fixed to inner tubularmember 77, and gear 574 may be coaxially inserted over and fixed toinner drive shaft 21. Gears 572 and 574 may be sized to be, for example,in a 1:4 ratio, respectively, so that, if external drive shaft 29rotates at about 6000 rpm, inner tubular member 77 also rotates at about6000 rpm whereas inner drive shaft 21 rotates at about 1500 rpm.

Referring now to FIG. 17, there is shown a fragmentary side view of analternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 580. Certain aspects of device 580 not important to anunderstanding of the invention are neither shown nor described herein.

Device 580 may be similar in many respects to device 6. One differencebetween the two devices may be that, whereas device 6 may fix innerdrive shaft 21 to external drive shaft 29 for rotation therewith and maycouple the rotation of inner tubular member 77 to inner drive shaft 21through the engagement of shaft 72 and gear 51, device 580 instead maycouple the rotation of inner drive shaft 21 to external drive shaft 29through the engagement of a pair of spur gears 582 and 584 and maycouple the rotation of inner tubular member 77 to external drive shaft29 through the engagement of a spur gear 586 with gear 582. Gear 582 maybe coaxially inserted over and fixed to external drive shaft 29, gear584 may be coaxially inserted over and fixed to inner drive shaft 21,and gear 586 may be coaxially inserted over and fixed to inner tubularmember 77. Gears 582 and 584 may be sized to be, for example, in a 1:2ratio, respectively, and gears 582 and 586 may be sized to be, forexample, in a 2:1 ratio, respectively. In this manner, if external driveshaft 29 rotates at about 3000 rpm, inner tubular member 77 rotates atabout 6000 rpm and inner drive shaft 21 rotates at about 1500 rpm.

Referring now to FIG. 18, there is shown a fragmentary perspective viewof an alternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 600. Certain aspects of device 600 not important to anunderstanding of the invention are neither shown nor described herein.

Device 600 may be similar in many respects to device 6. One differencebetween the two devices may be their respective mechanisms for rotatingand translationally reciprocating inner tubular member 77. Morespecifically, device 600 may comprise an internal drive shaft 603 fixedto an external drive shaft (not shown) so as to rotate therewith.Internal drive shaft 603 may comprise a proximal portion 605 and adistal portion 607. A spur gear 609 and a bevel gear 611 may becoaxially mounted over distal portion 607 and fixed thereto for rotationtherewith, with bevel gear 611 being positioned distally relative tospur gear 609. A spur gear 613 may be coaxially mounted over innertubular member 77 and fixed thereto for rotation therewith, gear 613being engaged with gear 609 so that the rotation of internal drive shaft603 causes the rotation of inner tubular member 77. (The speed ofrotation of inner tubular member 77, as compared to that of drive shaft603, may be controlled by the relative diameters of gears 609 and 613).A bevel gear 615, positioned distally relative to internal drive shaft603, may be engaged with bevel gear 611. A saddle 619 may be coaxiallymounted over inner tubular member 77, saddle 619 being fixed to innertubular member 77 for translational movement therewith but permittingtubular member 77 to freely rotate therewithin. Saddle 619 and bevelgear 615 may be coupled to one another by a pin (not shown) extendingupwardly from the top surface 621 of gear 615 and a slot (not shown)provided on the bottom surface of saddle 619, the slot in saddle 619receiving the pin on bevel gear 615. The slot in saddle 619 may beoriented perpendicularly to the longitudinal axis of inner tubularmember 77 and may be appropriately dimensioned so that the pin on bevelgear 615 travels back and forth within the slot in saddle 619 as bevelgear 615 rotates. In this manner, the rotation of bevel gear 615 maycause the translational oscillation of inner tubular member 77.

Referring now to FIG. 19, there is shown a fragmentary perspective viewof an alternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 700. Certain aspects of device 700 not important to anunderstanding of the invention are neither shown nor described herein.

Device 700 may be similar in many respects to device 6. One differencebetween the two devices may be their respective mechanisms for rotatingand translationally reciprocating inner tubular member 77. Morespecifically, device 700 may comprise an internal drive shaft 703 fixedto an external drive shaft (not shown) so as to rotate therewith. A spurgear 705 and a translation cam 707 may be coaxially mounted over driveshaft 703 and fixed thereto for rotation therewith, with translation cam707 being positioned distally relative to spur gear 705. A spur gear 711may be coaxially mounted over inner tubular member 77 and fixed theretofor rotation therewith, gear 711 being engaged with gear 705 so that therotation of internal drive shaft 703 causes the rotation of innertubular member 77. (The speed of rotation of inner tubular member 77, ascompared to that of drive shaft 703, may be controlled by the relativediameters of gears 705 and 711). A saddle 713 may be coaxially mountedover inner tubular member 77, saddle 713 being fixed to inner tubularmember 77 for translational movement therewith but permitting tubularmember 77 to freely rotate therewithin. Saddle 713 and translation cam707 may be coupled to one another by a pin (not shown) extendingdownwardly from saddle 713 and a looped groove 717 provided in cam 707,groove 717 receiving the pin on saddle 713. Groove 717 in cam 707 may beshaped to extend from about the proximal end 707-1 of cam 707 to aboutthe distal end 707-2 of cam 707 and back to about the proximal end 707-1of cam 707 over the course of one rotation of cam 707. In this manner,as cam 707 rotates and the pin travels back and forth within groove 717,inner tubular member 77 may be translationally oscillatedcorrespondingly.

Referring now to FIG. 20, there is shown a fragmentary perspective viewof an alternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 800. Certain aspects of device 800 not important to anunderstanding of the invention are neither shown nor described herein.

Device 800 may be similar in many respects to device 6. One differencebetween the two devices may be their respective mechanisms for rotatingand translationally reciprocating inner tubular member 77. Morespecifically, device 800 may comprise an internal drive shaft 801 fixedto an external drive shaft (not shown) so as to rotate therewith. A spurgear 803 may be coaxially mounted over drive shaft 801 and fixed theretofor rotation therewith. In addition, a translation cam 805 may becoaxially mounted over drive shaft 801 and fixed thereto for rotationtherewith. Translation cam 805 may comprise a tubular portion 805-1 anda disc portion 805-2, disc portion 805-2 being fixedly mounted ontubular portion 805-1 at a non-perpendicular angle relative to thelongitudinal axis of tubular portion 805-2. A spur gear 813 may becoaxially mounted over inner tubular member 77 and fixed thereto forrotation therewith, gear 813 being engaged with gear 803 so that therotation of internal drive shaft 801 causes the rotation of innertubular member 77. (The speed of rotation of inner tubular member 77, ascompared to that of drive shaft 801, may be controlled by the relativediameters of gears 803 and 813). A saddle 819 may be coaxially mountedover inner tubular member 77, saddle 819 being fixed to inner tubularmember 77 for translational movement therewith but permitting tubularmember 77 to freely rotate therewithin. Saddle 819 may be shaped toinclude a recess 821, which may receive the top of disc portion 805-2.In this manner, as drive shaft 801 rotates, causing disc portion 805-2to “wobble” back and forth, saddle 819, and thus inner tubular member77, may be translationally oscillated correspondingly.

Referring now to FIG. 21, there is shown a fragmentary perspective viewof an alternate tissue removal device that may be used in tissue removalsystem 5, said tissue removal device being represented generally byreference numeral 900. Certain aspects of device 900 not important to anunderstanding of the invention are neither shown nor described herein.

Device 900 may be similar in many respects to device 6. One differencebetween the two devices may be their respective mechanisms for rotatingand translationally reciprocating inner tubular member 77. Morespecifically, device 900 may comprise an internal drive shaft 901 fixedto an external drive shaft (not shown) so as to rotate therewith. A spurgear 903 and a worm gear 905 may be coaxially mounted over drive shaft901 and fixed thereto for rotation therewith. A spur gear 907 may becoaxially mounted over inner tubular member 77 and fixed thereto forrotation therewith, gear 907 being engaged with gear 903 so that therotation of internal drive shaft 901 causes the rotation of innertubular member 77. (The speed of rotation of inner tubular member 77, ascompared to that of drive shaft 901, may be controlled by the relativediameters of gears 903 and 907). A worm gear 911 may be engaged withworm gear 905 so that worm gear 911 rotates as worm gear 905 rotates. Apin 913 may be mounted near the periphery of a front face 911-1 of wormgear 911. A reciprocation arm 915 may have a first end secured to pin913 and a second end secured to a block 917 translationally coupled toinner tubular member 77. In this manner, as worm gear 911 rotates andthe position of pin 913 on worm gear 911 changes, arm 915 moves block917 and inner tubular member 77 back and forth translationally.

As can be appreciated, one would like to minimize the amount ofdistension fluid that flows from the uterus of the patient through thetissue removal device when the tissue removal device is left in thepatient but the cutting motor for the tissue removal device hastemporarily been turned off, e.g., during those periods when theoperator of the tissue removal device stops cutting to examine thepatient. Such a loss of distension fluid is undesirable for at least thereason that the lost distension fluid will need to be replenished inorder to keep the uterus distended. In device 6, this problem may beaddressed through electronics by sensing when the motor for device 6 isabout to be turned off and, in those instances, by positioning innertubular member 77 translationally relative to outer tubular member 76 sothat resection window 89 is closed. An alternate approach to thisproblem is exemplified by tissue removal device 940, which is shown inFIGS. 22( a) through 22(e). Certain aspects of device 940 not importantto an understanding of the invention are neither shown nor describedherein.

Device 940 is similar in certain respects to device 6. However, onedifference between the respective devices is that device 940 maycomprise an inner tubular member 943 having a closed proximal end 945and a side window 947. A spring mount 949 may be coaxially mounted overinner tubular member 943 and fixed thereto for rotation therewith. Theproximal end of a spring 951 may be fixed to spring mount 949, and thedistal end of spring 951 may be fixed to a valve member 953 coaxiallymounted over inner tubular member 943, valve member 953 being capable ofrotating relative to inner tubular member 943. Valve member 953 mayinclude a side window 955. Side window 955 may be alignable with sidewindow 943 depending on the respective rotational positions of innertubular member 943 and valve member 953. A stop 957 may be formed oninner tubular member 943, stop 957 being detachably engageable withvalve member 953 to couple the rotation of valve member 953 with innertubular member 943. A vacuum housing 959 may be coaxially mounted overvalve member 953, valve member 953 being freely rotatable within vacuumhousing 959. Outer tubular member 76 may be fixedly mounted on vacuumhousing 959. A pair of O-rings 961-1 and 961-2 may be provided tofunction as seals.

Prior to the cutting motor of device 940 being actuated, side window 955of valve member 953 and side window 947 of inner tubular member 943 are90 degrees out of register with one another. However, once the cuttingmotor of device 940 is actuated, inner tubular member 943 begins torotate. This causes spring 951 to try to unwind, thereby causing valvemember 953 to rotate so that side window 955 of valve member 953 isaligned with side window 947 of inner tubular member 943. With valvemember 953 thus rotationally aligned with inner tubular member 943, stop957 prevents further rotation of valve member 953 relative to innertubular member 943. When the cutting motor of device 940 is then turnedoff, spring 951 causes valve member 953 to be rotated back to itsoriginal orientation relative to inner tubular member 943.

As noted above, introducer 7 preferably comprises valve 233, which isdesigned to keep fluid from escaping from the patient when device 6 isnot inserted into introducer 7. However, there may be situations inwhich it is desirable to simultaneously have fluid flowing into and outof the patient without having device 6 inserted into introducer 7.Therefore, referring now to FIG. 23, there is shown a fragmentarysection view of an obturator 965 positioned within a channel ofintroducer 7. Obturator 965 may be shaped to include a blunt distal end967 and a plurality of openings 969 leading to alongitudinally-extending channel 971. Obturator 965 may be positioned ininstrument channel 196, as shown, or may be positioned in fluid inputchannel 198-1 or fluid input channel 198-2 to provide bidirectionalfluid flow (for example, with fluid inflow exiting channels 198-1 or198-2 in the space between channels 198-1 or 198-2 and obturator 965 andwith fluid outflow entering obturator 965 through openings 969). Thefluid outflow entering channel 971 through openings 969 may exitobturator 965 through the proximal end (not shown) of obturator 965.

An alternate obturator 972 is shown in FIG. 24, obturator 972 having aside opening 973 at an intermediate location along its length, sideopening 973 being aligned with an outflow fluid channel 975 provided inan alternate introducer 977. If desired, obturator 972 may be made of aresilient member having a bend and introducer 977 may be provided with asheath 978 made of a flexible material. In this manner, obturator 972may be used to provide a bend to sheath 978, which, by rotating theproximal end 979 of obturator 972, may be used to steer the distal endof sheath 978.

Referring now to FIGS. 25( a) and 25(b), there is shown an alternatecombination of an obturator and an introducer according to the presentinvention, the obturator being represented generally by referencenumeral 980 and the introducer being represented generally by referencenumeral 981.

Obturator 980, which may be similar in many respects to obturator 965,may comprise a distal member 982 and a proximal member 983. Distalmember 982 may be tubular and may comprise an open distal end 984, aclosed proximal end 985, and a side opening 986, with proximal member983 being mounted over proximal end 985 of distal member 982.

Introducer 981 may be similar in many respects to introducer 7, onedifference between the respective introducers being that introducer 981may additionally comprise a fluid outflow channel 987. Channel 987 maycomprise a distal end 987-1 that may be aligned with side opening 986 ofobturator 980 when obturator 980 is installed in introducer 981. In thismanner, outflow fluid may flow from obturator 980 to channel 987 and mayexit introducer 981 through a proximal end 987-2 of channel 987.Introducer 981 may additionally comprise a valve 988-1 and a valve989-2. Valve 988-1, which may be a stopcock valve, may be used tocontrol the flow of fluid through channel 987. Valve 988-2, which may bea stopcock valve, may be used to control the flow of fluid throughinflow channel 989.

Referring now to FIGS. 26( a) through 26(c), there are shown variousviews of an alternate introducer device to introducer device 7, thealternate introducer device being represented generally by referencenumeral 990.

Introducer device 990 may be similar in many respects to introducerdevice 7. One difference between introducer device 990 and introducerdevice 7 may be that, whereas introducer device 7 may comprise a sheath191 having a top lumen 196, a bottom lumen 197 and a pair of side lumens198-1 and 198-2, introducer device 990 may comprise a top tubular member991, a bottom tubular member 992, a sleeve 993, and a distal cap 994.Top tubular member 991 may be used, for example, as an instrumentchannel to receive, for example, tissue removal device 6 or obturator965. Bottom tubular member 992 may be used, as is shown, for example, toreceive distal end 319 of hysteroscope 8. Sleeve 993, which may be madeof stainless steel or the like, may be appropriately dimensioned tocoaxially receive top tubular member 991 and bottom tubular member 992and may be shaped to define a pair of fluid channels 995 on oppositesides of tubular members 991 and 992 in the spaces between the innersurface of sleeve 993 and the outer surfaces of tubular members 991 and992. A plurality of transverse openings 996 may be provided in sleeve993 near the distal end 997 thereof, openings 996 providing side accessto fluid channels 995. In this manner, fluid inflow to the patient maybe provided by having the fluid pass distally through channels 995 andthen exit radially through openings 996. Fluid outflow from the patientmay travel proximally through cap 994 and then proximally through toptubular member 991 (for example, by passing through an instrumentpositioned in top tubular member 991). It is believed that the fluidflow pattern provided by introducer device 990 may be particularlyeffective in removing blood and other undesired fluids from a patient.Cap 994 may include a retainer 998, which may receive the distal ends oftubular members 991 and 992 and which may be inserted into and fixed tothe distal end 997 of sleeve 993.

Referring now to FIG. 27, there is shown a partially explodedperspective view of a second embodiment of a tissue removal system, thetissue removal system being constructed according to the teachings ofthe present invention and being represented generally by referencenumeral 1007.

System 1007 may comprise a tissue removal device 1008, a vacuum assembly1009, and a motor drive assembly 1010. Although not shown in the presentembodiment, system 1007 may also include an introducer device, aflexible hysteroscope, and a fluid supply similar to those of system 5described above.

Tissue removal device 1008 may comprise a morcellator assembly 1013 anda drive assembly 1015, morcellator assembly 1013 being removably mountedon drive assembly 1015 in the manner described further below.

Referring now to FIGS. 28( a) through 28(d), morcellator assembly 1013may be seen in greater detail. Morcellator assembly 1013 may comprise ahousing 1021. Housing 1021, which may be an elongated unitary structuremade of a rigid polymer or metal, may be a generally tubular membershaped to include a proximal end 1023, a distal end 1025, and a sidewall 1027. Side wall 1027 may be generally cylindrical, with a portion1028 of its bottom surface being beveled. A longitudinal lumen 1029 mayextend from proximal end 1023 to distal end 1025. An intermediateportion 1031 of lumen 1029 may be expanded in diameter and may beaccessible through an opening 1033 in side wall 1027. A proximal portion1035 of lumen 1029 extending distally from proximal end 1023 to a pointspaced proximally from intermediate portion 1031 may be expanded indiameter and may be internally threaded.

Morcellator assembly 1013 may additionally comprise a pair of tubularbushings 1041 and 1043. Bushing 1041, which may be a unitary structuremade of a rigid polymer or metal, may be seated within intermediateportion 1031 of lumen 1029, near its proximal end, and may be fixedlysecured to housing 1021 with screws 1042. Bushing 1043, which may be aunitary structure made of a rigid polymer or metal, may be seated withinintermediate portion 1031 of lumen 1029, near its distal end, and may befixedly secured to housing 1021 with screws 1044. Bushing 1041 may beshaped to include a bore 1045, and bushing 1043 may be shaped to includea bore 1047, bores 1045 and 1047 being coaxially aligned with lumen 1029of housing 1021.

Morcellator assembly 1013 may further comprise an elongated shaft 1051.Shaft 1051, which may be a unitary structure made of brass or anothersuitable rigid metal or polymer, may be shaped to include a proximalportion 1053, a distal portion 1055, an intermediate portion 1057, and alongitudinal bore 1059. Proximal portion 1053 of shaft 1051 may beslidably mounted in bore 1045 of bushing 1041 and may be sized to freelyrotate therewithin. Distal portion 1055 of shaft 1051 may be slidablymounted in bore 1047 of bushing 1043 and may be sized to freely rotatetherewithin. Intermediate portion 1057 of shaft 1051 may be positionedbetween bushings 1041 and 1043 and may be in the shape of a gear havingan enlarged external diameter relative to proximal portion 1053 anddistal portion 1055.

Morcellator assembly 1013 may further comprise a translational couplingblock 1061. Block 1061, which may be a unitary structure made of a rigidpolymer or metal, may be a tubular member shaped to include a proximalend 1063, a distal end 1064, a side wall 1065, and a longitudinal bore1066. Block 1061 may be coaxially mounted over proximal portion 1053 ofshaft 1051, with bore 1066 being sized relative to proximal portion 1053so that proximal portion 1053 may freely rotate within bore 1066. Sidewall 1065 of block 1061 may be shaped to correspond generally to theshape of intermediate portion 1031 of lumen 1029. In this manner, block1061 may be kept rotationally stationary within housing 1021. Block 1061may be translationally fixed relative to shaft 1051 with a retainingring 1067 inserted coaxially over proximal portion 1053 and secured toproximal portion 1053 with a set screw 1068. A washer 1069 may beinserted coaxially over proximal end 1053 of shaft 1051 between distalend 1063 of block 1061 and intermediate portion 1057 of shaft 1051 toprevent any wear caused by contact between intermediate portion 1057against distal end 1063 of block 1061 as intermediate portion 1057rotates. Side wall 1065 of block 1061 may further be shaped to include awaist 1070 of reduced external diameter. In this manner, with block 1061coaxially mounted over proximal portion 1053 of shaft 1051, a pair ofslots 1071-1 and 1071-2 may be formed between block 1061 and housing1021.

Morcellator assembly 1013 may further comprise a strain relief member1072. Strain relief member 1072, which may be a unitary structure madeof a rigid polymer or metal, may be a tubular member shaped to include aproximal portion 1073 and a distal portion 1074. Proximal portion 1073may be slightly greater in diameter than distal portion 1074 and mayinclude a bifurcating slot 1075. Proximal portion 1073 of strain reliefmember 1072 may be disposed within the distal portion of lumen 1029,with distal portion 1074 of strain relief member 1072 extending distallyfrom distal end 1025 of housing 1021 for a short distance, such as, forexample, approximately 2 inches.

Morcellator assembly 1013 may further comprise a cutting mechanism. Inthe present embodiment, the cutting mechanism may comprise an outertubular member 1076 and an inner tubular member 1077, inner tubularmember 1077 moving rotationally and, at the same time, oscillatingtranslationally relative to outer tubular member 1076 in the manner tobe described further below. Outer tubular member 1076, which may be aunitary structure made of stainless steel or another similarly suitablematerial, may be shaped to include an open proximal end 1079, a closeddistal end 1081, and a lumen 1083 extending from open proximal end 1079to a point just prior to closed distal end 1081. Member 1076 may becoaxially mounted within strain relief member 1072, with proximal end1079 of member 1076 disposed within proximal portion 1073 of strainrelief member 1072 and with distal end 1081 of member 1076 extendingdistally beyond distal portion 1074 of strain relief member 1072 for anextended distance, such as, for example, five inches. The combination ofproximal end 1079 of member 1076 and proximal portion 1073 of strainrelief member 1072 may be securely retained in housing 1021 using ascrew 1085 inserted through an opening 1087 in housing 1021, screw 1085pressing proximal portion 1073 of strain relief member 1072 tightlyagainst proximal end 1079 of member 1076.

Outer tubular member 1076 may be further shaped to include a resectionwindow 1089 into which tissue may be captured and drawn, window 1089being located proximate to distal end 1081, such as, for example, 0.25inch from distal end 1081. Window 1089 may be shaped to include aproximal end 1089-1 and a distal end 1089-2. Proximal end 1089-1 mayslope gradually proximally, and distal end 1089-2 may slope graduallydistally. More specifically, window 1089 may have a length ofapproximately 0.55 inch, proximal end 1089-1 may be a radial end havinga radius of curvature of, for example, 0.085 inch, and distal end 1089-2may be a radial end having a radius of curvature of, for example, 0.150inch. Window 1089 may extend over a substantial portion of thecircumference of tubular member 1076, such as, for example, about 60% ofthe circumference.

Outer tubular member 1076 may have an outer diameter less than about 5.5mm. However, in order to reduce the risk of injury to the patient and inorder to obviate the need for anesthesia to be administered to thepatient, outer tubular member 1076 preferably has an outer diameter lessthan about 5 mm, more preferably less than 4 mm, even more preferablyless than 3 mm, and still even more preferably less than 2 mm.

Inner tubular member 1077, which may be an elongated unitary structuremade of stainless steel or another similarly suitable material, may beshaped to include a proximal end 1091, a distal end 1092, and alongitudinal lumen 1093. Distal end 1092 may be shaped to include anexternal bevel, such as, for example, an external bevel of approximately20 degrees. An intermediate portion of tubular member 1077 may bereceived within bore 1059 of shaft 1051 and may be fixedly coupled toshaft 1051 for translational and rotational movement therewith using aretaining ring 1094-1, a slotted sleeve 1094-2 and a pair of set screws1095. The proximal portion of ring 1094-1 may be screwed onto the distalend of shaft 1051, with the distal portion of ring 1094-1 extending overmember 1077. Sleeve 1094-2 may be inserted coaxially between member 1077and ring 1094-1, and set screws 1095 may be inserted through atransverse opening 1096 in retaining ring 1094-1 to couple ring 1094-1and sleeve 1094-2 to member 1077. Tubular member 1077 may have asuitable length so that, when tubular member 1077 is in a fullyretracted (i.e., proximal) position, proximal end 1091 of tubular member1077 may extend proximally a short distance from proximal end 1023 ofhousing 1021 and distal end 1092 of tubular member 1077 may be withdrawnsufficiently to permit tissue to enter window 1089. At the same time,tubular member 1077 may have a length so that, when tubular member 1077is in a fully advanced (i.e., distal) position, distal end 1092 oftubular member 1077 may be positioned distally of distal end 1089-2 ofwindow 1089.

Morcellator assembly 1013 may further comprise a fitting 1097. Fitting1097, which may be a unitary structure made of a rigid polymer or metal,may be a tubular member shaped to include a proximal portion 1098, adistal portion 1099 and a longitudinal lumen 1100. Proximal portion1098, which may be barbed, may be coupled through a length of tubing tovacuum assembly 1009. Distal portion 1099 of fitting 1097 may beexternally threaded for mating engagement with proximal portion 1035 ofhousing 1021. Lumen 1100 of fitting 1097 may be dimensioned to slidablyreceive proximal end 1091 of tubular member 1077. An O-ring 1101 may bedisposed within lumen 1100 to provide a seal around tubular member 1077.

Referring now to FIGS. 29( a) and 29(b), drive assembly 1015 may be seenin greater detail. Drive assembly 1015 may include a main body 1105.Main body 1105, which may be a unitary structure made of a rigid polymeror metal, may be a generally trough-shaped member shaped to include adistal end 1107, a proximal end 1109, and a side wall 1111. Distal end1107 may be generally circular and may include a distal surface thatincludes a central portion 1115 and a peripheral portion 1117. Centralportion 1115 may be recessed relative to peripheral portion 1117. Acentral transverse opening 1119 may be provided in central portion 1115,and a pair of smaller transverse openings 1120 may be provided incentral portion 1115 on opposite sides of central opening 1119. Proximalend 1109 may be generally circular and may include a proximal surfacethat includes a central portion 1123 and a peripheral portion 1125.Central portion 1123 may be recessed relative to peripheral portion1125. A central transverse opening 1127 may be provided in centralportion 1123, and a pair of smaller transverse openings 1129 may beprovided in central portion 1123 on opposite sides of central opening1127. Side wall 1111 may extend from distal end 1107 to proximal end1109 but only over about the top half of their respectivecircumferences. A longitudinal groove 1131 may be provided along theouter surface of side wall 1111 to receive a corresponding portion ofhousing 1021 of morcellator assembly 1013. Groove 1131 may include afirst transverse slot 1133 extending though side wall 1111 and a secondtransverse slot 1135 extending through side wall 1111. First transverseslot 1133 may be spaced a short distance from distal end 1107 and may beoriented generally circumferentially relative to side wall 1111. Secondtransverse slot 1135 may be spaced a short distance from proximal end1109 and from first transverse slot 1133 and may be oriented generallylongitudinally relative to side wall 1111. The inner surface of sidewall 1111 may additionally be shaped to include a block 1141 locatedbetween first transverse slot 1133 and second transverse slot 1135.Block 1141 may be shaped to include an exterior groove 1143 on itsbottom surface, groove 1143 extending parallel to second transverse slot1135. A bracket 1145, which may be a unitary structure made of a rigidpolymer or metal, may be secured to the bottom surface of block 1141with a pair of screws 1146. Bracket 1145 may be shaped to include agroove 1147 on its top surface that is complementarily shaped to groove1143, with grooves 1143 and 1147 jointly defining a channel of generallycylindrical shape.

Drive assembly 1015 may additionally comprise a mechanism for drivingrotational movement of inner tubular member 1077. Such a mechanism maycomprise a first motor 1151. Motor 1151, in turn, may comprise a firstend 1152 having a shaft 1153 extending therefrom. First end 1152 may bereceived within central portion 1115 of distal end 1107 of body 1105 andmay be secured thereto with screws 1156 inserted through openings 1120and into complementary openings 1157 in first end 1152 of motor 1151.With motor 1151 thus secured to distal end 1107, shaft 1153 may extendthrough central transverse opening 1119 and may freely rotatetherewithin. Cables 1159 may be used to connect motor 1151 to controlunit 1010.

In addition, the aforementioned mechanism for driving rotationalmovement of inner tubular member 1077 may further comprise a couplingblock 1161 and a gear 1162. Coupling block 1161, which may be a unitarystructure made of a rigid polymer or metal, may be shaped to include adistal base 1163 and a proximal post, the proximal post extendingproximally from base 1163. Base 1163 may be shaped to include a cavity1164 accessible from its distal end into which shaft 1153 of motor 1151may be received and secured with a screw 1165, thereby mechanicallycoupling shaft 1153 to block 1161. The proximal post may be shaped toinclude a distal portion 1166 of increased diameter and a proximalportion 1167 of decreased diameter. Gear 1162, which may be a unitarymember made of a rigid polymer or metal, may be shaped to include adistal tube 1168 and a proximal toothed wheel 1169. Tube 1168 may becoaxially mounted on portion 1166 of block 1161 and mechanically coupledthereto with a screw 1170. Wheel 1169 may be positioned so that aportion of wheel 1169 extends through slot 1133 for engagement withintermediate portion 1057 of shaft 1051. In this manner, rotation ofwheel 1169 causes the rotation of shaft 1051. Proximal portion 1167 ofpost 1165, which may extend proximally a short distance beyond wheel1169, may be seated within a bearing 1173, bearing 1173 being seatedwithin the distal end of the channel jointly defined by block 1141 andbracket 1145.

Drive assembly 1015 may further comprise a mechanism for drivingoscillating translational movement of inner tubular member 1077. Such amechanism may comprise a second motor 1181. Motor 1181, in turn, maycomprise a first end 1182 having a shaft 1183 extending therefrom. Firstend 1182 may be received within central portion 1123 of proximal end1109 of body 1105 and may be secured thereto with screws 1186 insertedthrough openings 1129 and into complementary openings 1187 in first end1182 of motor 1181. With motor 1181 thus secured to proximal end 1109,shaft 1183 may extend through central transverse opening 1127 and mayfreely rotate therewithin. A cable 1189 may be used to connect motor1181 to control unit 1010.

In addition, the aforementioned mechanism for driving oscillatingtranslational movement of inner tubular member 1077 may further comprisea coupling block 1191, a threaded bolt 1192, and a carriage 1193.Coupling block 1191, which may be a unitary structure made of a rigidpolymer or metal, may be shaped to include a proximal opening 1194 and adistal opening 1195. Proximal opening 1194 may be dimensioned tosecurely receive shaft 1183 of motor 1181, thereby mechanically couplingshaft 1183 to block 1191. Distal opening 1195 may be dimensioned tosecurely receive the proximal end of threaded bolt 1192, therebymechanically coupling bolt 1192 to block 1191. The distal end of bolt1192 may be seated within a bearing 1196, which, in turn, may be seatedwithin the proximal end of the channel jointly defined by block 1141 andbracket 1145. Carriage 1193, which may be a unitary structure made of arigid polymer or metal, may be shaped to include a bore 1197 and a pairof upwardly extending tines 1198. A rigid collar 1199 may be fixedlymounted within bore 1197 of carriage 1193 using a pair of screws 1200.Collar 1199 may be internally threaded to engage bolt 1192. In thismanner, as bolt 1192 rotates, carriage 1193 moves translationally alongthe longitudinal axis of bolt 1192, with proximal or distaltranslational movement of carriage 1193 effected by the clockwise orcounterclockwise rotation, respectively, of bolt 1192. Carriage 1193 maybe mechanically coupled for translational movement to shaft 1051 bytines 1198, with tines 1198 extending through slot 1135 of body 1105 andbeing received within slots 1071-1 and 1071-2 of morcellator assembly1013.

As can be appreciated from the above description, the speed at whichinner tubular member 1077 rotates and the speed at which inner tubularmember 1077 oscillates translationally are separately and independentlycontrolled, with the rotation of inner tubular member 1077 beingcontrolled by motor 1151 and with the oscillating translation of innertubular member 1077 being controlled by motor 1181.

Drive assembly 1015 may further comprise a body 1201. Body 1201, whichmay be a unitary structure made of a rigid polymer or metal, may beshaped to include a distal end 1203, a proximal end 1205, a side wall1207, and a cavity 1208. Distal end 1203 may be generally semi-circularin shape, and proximal end 1205 may be generally semi-annular in shape.Side wall 1207 may be semi-annular in transverse cross-section and mayextend from distal end 1203 to proximal end 1205. A longitudinal groove1209, similar in shape to groove 1131 of body 1105, may be providedalong the top, outer surface of side wall 1207 to receive acorresponding portion of housing 1021 of morcellator assembly 1013.Cavity 1208 may be dimensioned to receive motor 1151. A pair oflongitudinal lumens 1213 may be provided in body 1201, lumens 1213extending through distal end 1203, proximal end 1205, and side wall1207. Lumens 1213 may be aligned with corresponding threaded cavities1215 in body 1105 so that proximal end 1205 of body 1201 and may befixed to distal end 1107 of body 1105 using screws 1217 inserted throughbody 1201 and into cavities 1215.

Drive assembly 1015 may further comprise a locking clip 1221. Lockingclip 1221, which may be a unitary structure made of a rigid polymer ormetal, may be shaped to include a base 1223, a pair of parallel legs1225, and a pair of parallel feet 1227. Legs 1225 may extend upwardlyfrom base 1223, with legs 1225 being spaced inwardly a short distancefrom the ends of base 1223. Feet 1227 may extend transversely from legs1225. Base 1223 may be received within a matingly-shaped recess 1229provided on body 1105 and may be securely retained within recess 1229 bysecuring body 1201 to body 1105. With clip 1221 thus mounted on body1105, legs 1225 extend upwardly beyond body 1105 and may be insertedinto corresponding L-shaped slots 1230 in housing 1021 of morcellatorassembly 1013. In this manner, clip 1221 may be used to reversibly andlockably couple drive assembly 1015 to morcellator assembly 1013. Morespecifically, to lockably couple drive assembly 1015 to morcellatorassembly 1013, one may insert feet 1227 into the proximal portions1230-1 of slots 1230 and may then slide feet 1227 distally to the distalportions 1230-2 of slots 1230. To uncouple drive assembly 1015 frommorcellator 1013, feet 1227 may be slid proximally from distal portions1230-2 to proximal portions 1230-1 and may then be removed from slots1230.

Drive assembly 1015 may further comprise a body 1231. Body 1231, whichmay be a unitary structure made of a rigid polymer or metal, may be agenerally cylindrical member shaped to include a proximal end 1233, adistal end 1235, and a side wall 1237. A cavity 1239 may extendproximally from distal end 1235, cavity 1239 being dimensioned toreceive substantially all but first end 1182 and shaft 1183 of motor1181. A pair of longitudinal lumens 1241 may be provided in body 1231,lumens 1241 extending through proximal end 1233, distal end 1235, andside wall 1237. Lumens 1241 may be aligned with corresponding threadedcavities 1242 in body 1105 so that distal end 1235 of body 1231 may befixed to proximal end 1109 of body 1105 using screws 1243 insertedthrough body 1231 and into cavities 1242. A groove 1245 may extendlongitudinally from proximal end 1233 to distal end 1235 along the topsurface of side wall 1237. Groove 1245 may be aligned with groove 1131of body 1105 in order to receive a corresponding portion of housing 1021of morcellator assembly 1013.

Drive assembly 1015 may further comprise an endplate 1251. Endplate1251, which may be a unitary structure made of a rigid polymer or metal,may be a generally disc-shaped structure shaped to include a retainingloop 1253 at its top. Retaining loop 1253 may be dimensioned to receivethe proximal end of housing 1021 of morcellator assembly 1013. A pair ofopenings 1255 may be provided in endplate 1251. Openings 1255 may bealigned with corresponding threaded cavities 1257 in body 1231 so thatendplate 1241 may be fixed to proximal end 1233 of body 1231 usingscrews 1259 inserted through endplate 1241 and into cavities 1257.

Drive assembly 1015 may further comprise a cover 1261. Cover 1261, whichmay be a unitary structure made of a rigid polymer or metal, may be inthe shape of a half-pipe having a proximal end 1263 and a distal end1265. Cover 1261 may be dimensioned to complement side walls 1111 and1207 of bodies 1105 and 1201, respectively. In addition, cover 1261 maybe fixed to body 1105 with a screw 1267 inserted through an opening 1269in cover 1261 and into a corresponding cavity 1271 in proximal end 1109of body 1105 and with a screw 1273 inserted through an opening 1275 incover 1261 and into a corresponding cavity 1277 in distal end 1107 ofbody 1105. Additionally, cover 1261 may be fixed to body 1201 by joiningcover 1261 to a block 1281 using a screw 1283 and by joining block 1281to distal end 1203 of body 1201 using a pair of screws 1285.

Referring back now to FIG. 27, vacuum assembly 1009 may include aspecimen collection container 1291 and a vacuum source 1292. The distalend of an evacuation tube 1293 may be inserted over fitting 1097 and maybe secured thereto by a friction fit, and the proximal end of evacuationtube 1293 may be coupled to a first port 1294 of container 1291. Thedistal end of a tube 1295 may be coupled to a second port 1296 ofcontainer 1291, and the proximal end of tube 1295 may be coupled tovacuum source 1292. In this manner, vacuum source 1292 may be used toapply suction to device 1008, and any withdrawn tissue, liquids orsimilar matter suctioned through device 1008 may be collected incontainer 1291.

Control unit 1010, which may be coupled to a source of electricity, suchas an AC wall outlet, using a power cord (not shown), may includeelectronics (not shown) for controlling the operation of motors 1151 and1181 using a cable 1298-1 connected to cables 1159 and 1189. A footpedal 1297 may be coupled to control unit 1010 by a cable 1298-2 and maybe used as a power switch to selectively activate or de-activate motors1151 and 1181. Control unit 1010 may further include a vacuum sensor1299, which may be coupled to container 1291 by a tube 1300, so that thepressure within container 1291 may be monitored by control unit 1010. Inthis manner, a sudden increase in vacuum pressure may indicate that aclog has occurred. The presence of a clog may be indicated via an alarm(not shown) located on control unit 1010. The detection of a clog isoften a clear indication that the further operation of device 1008 mayonly aggravate the clogging situation and that a cessation of tissueremoval may be necessary. Control unit 1010 may be configured tosynchronize actuation of drive assembly 1015 with actuation of vacuumsource 1292. In this manner, turning on drive assembly 1015 will turn onvacuum source 1292 at the same time. Correspondingly, vacuum source 1292may be deactivated whenever drive assembly 1015 is turned off.

In use, the distal end of a hysteroscope may be inserted transcervicallyinto a patient, and a suitable fluid may be conducted through the inletfluid port of the hysteroscope into the uterus until the uterus isdistended. Observation of the uterus and detection of fibroids or otherabnormal gynecological tissues may then be performed using thevisualization channel of the hysteroscope. The distal ends of outertubular member 1076 and inner tubular member 1077 may be insertedthrough a working channel of the hysteroscope and into the uterus, withthe remainder of system 1007 remaining proximal to the hysteroscope.Device 1008 may then be manipulated so that window 1089 of outer tubularmember 1076 may be positioned in proximity to the fibroid or othertargeted tissue. Next, vacuum source 1292 may be operated so as to causesuction to be applied to inner tubular member 1077, thereby drawingtissue into outer tubular member 1076 through window 1089. In addition,motors 1151 and 1181 may be operated so as to cause inner tubular member1077 simultaneously to rotate and to oscillate back and forthtranslationally within outer tubular member 1076, thereby causing thetissue drawn through window 1089 to be cut. The cut tissue may then besuctioned from the patient through inner tubular member 1077 by means ofthe aforementioned suction and, thereafter, collected in container 1291.Once the fibroids or other targeted tissues have thus been removed fromthe patient, vacuum source 1292 and motors 1151 and 1181 may be turnedoff, device 1008 may be withdrawn from the hysteroscope, and thehysteroscope may be withdrawn from the patient. Morcellator assembly1013 may then be detached from drive assembly 1015 and disconnected fromvacuum source 1292. Morcellator assembly 1013 may be designed to be asingle use device and, if so, may be disposed of after being used on apatient. By contrast, drive assembly 1015 may be used on a number ofdifferent patients prior to its disposal, with a different morcellatorassembly 1013 preferably being used with each patient.

It should be noted that, although the above-discussion contemplatesinserting device 1008 through the working channel of a hysteroscope, onemay insert device 1008 transcervically into the uterus without the useof a hysteroscope. In such a situation, fluid may be administeredtranscervically to the uterus by a fluid dispensing device in order todistend the uterus, and, thereafter, observation of the uterus may beaccomplished, for example, by ultrasonic imaging using an ultrasonicprobe inserted transcervically into the uterus. Such an ultrasonic probemay be separate from device 1008 or may be integrated into device 1008.Alternatively, imaging of the uterus may be performed by MRI imaging.

Referring now to FIG. 30, there is shown a fragmentary explodedperspective view of an alternate tissue removal device adapted for usein system 1007, said tissue removal device being represented generallyby reference numeral 1450. For simplicity and clarity, certain aspectsof device 1450 not important to an understanding of the invention areneither shown nor described herein.

Device 1450 may be similar in most respects to device 1008, theprincipal differences between the two devices being that carriage 1193and translational coupling block 1061 of device 1008 may be replacedwith carriage 1461 and translational coupling block 1463, respectively,of device 1450. Carriage 1461 of device 1450 may be similar in manyrespects to carriage 1193 of device 1008, the principal differencebetween the two carriages being that carriage 1461 may include anupwardly biased spring-loaded pin 1465. Translational coupling block1463 of device 1450 may be similar in many respects to translationcoupling block 1061 of device 1008, the principal differences betweenthe two blocks being that (i) translation coupling block 1463 may beshaped to include a cavity 1467 adapted to receive pin 1465 and (ii)translation coupling block 1463 may be shaped to include ramped surfaces1469-1 and 1469-2 sloping downwardly towards the open end of cavity 1467from the proximal and distal ends, respectively, of translation couplingblock 1463. In use, the morcellator assembly, which comprisestranslation coupling block 1463, may be attached to the drive assembly,which comprises carriage 1461, and the translational motor of device1008 may be actuated to move carriage 1461 translationally back andforth one complete cycle. Regardless of where carriage 1461 andtranslational coupling block 1463 may be initially positionedtranslationally relative to one another, as carriage 1461 is movedtranslationally one complete cycle, pin 1465 is automatically assured ofbeing aligned with cavity 1467. For example, if pin 1465 is initiallypositioned proximally relative to translation coupling block 1463, ascarriage 1461 is moved distally, the top surface of pin 1465 travelsacross ramped surface 1469-1 and is then received in cavity 1467. Oneadvantage of this arrangement is that pin 1465 and cavity 1467 need notbe aligned with one another as the morcellator assembly and the driveassembly are attached to one other. As can be appreciated, because themorcellator assembly may be a single-use item whereas the drive assemblymay be a reusable item, pin 1465 and cavity 1467 may not initially bealigned with one another.

Referring now to FIGS. 31( a) and 31(b), there are shown fragmentary,partially exploded, perspective views of another alternate tissueremoval device adapted for use in system 1007, said tissue removaldevice being represented generally by reference numeral 1500. Forsimplicity and clarity, certain aspects of device 1500 not important toan understanding of the invention are neither shown nor describedherein.

Device 1500 may comprise a morcellator assembly 1513 and a driveassembly 1515. Morcellator assembly 1513 and drive assembly 1515 may besimilar in most respects to morcellator assembly 1013 and drive assembly1015, respectively, the principal differences between the respectivemorcellator assemblies and drive assemblies being that morcellatorassembly 1513 and drive assembly 1515 may be detachably matingly securedto one another by means of a detent 1517 provided on morcellatorassembly 1513 and a slot 1519 provided in drive assembly 1515.Accordingly, when one wishes to use device 1500, detent 1517 ofmorcellator assembly 1513 is preferably inserted into slot 1519 of driveassembly 1515, thereby physically and operatively coupling togethermorcellator assembly 1513 and drive assembly 1515. Device 1500 may thenbe used in the same manner discussed above in connection with device1008. After device 1500 has been used, morcellator assembly 1513 may beseparated from drive assembly 1515, for example, by pulling apart theirrespective proximal ends until detent 1517 is removed from slot 1519. Ifdesired, morcellator assembly 1513 may then be disposed of whereas driveassembly 1515 may be reused.

Referring now to FIG. 32, there is shown a fragmentary, partiallyexploded, perspective view of another alternate tissue removal deviceadapted for use in system 1007, said tissue removal device beingrepresented generally by reference numeral 1600. For simplicity andclarity, certain aspects of device 1600 not important to anunderstanding of the invention are neither shown nor described herein.

Device 1600 may comprise a morcellator assembly 1613 and a driveassembly 1615. Morcellator assembly 1613 and drive assembly 1615 may besimilar in most respects to morcellator assembly 1013 and drive assembly1015, respectively, the principal differences between the respectivemorcellator assemblies and drive assemblies being that morcellatorassembly 1613 and drive assembly 1615 may be detachably secured to oneanother by means of hooks 1617 provided on morcellator assembly 1613near its distal end and corresponding slots 1619 provided in driveassembly 1615 near its distal end. In addition, drive assembly 1615 mayfurther comprise a spring retention member 1621 at its proximal end forengaging the proximal end of morcellator 1613. Accordingly, when onewishes to use device 1600, hooks 1617 of morcellator assembly 1613 arepreferably inserted into slots 1619 of drive assembly 1615 and thenspring retention member 1621 engages the proximal end of morcellatorassembly 1613, thereby physically and operatively coupling togethermorcellator assembly 1613 and drive assembly 1615. Device 1600 may thenbe used in the same manner discussed above in connection with device1008. After device 1600 has been used, morcellator assembly 1613 may beseparated from drive assembly 1615, for example, by pulling apart theirrespective proximal ends until hooks 1617 are removed from slots 1619.If desired, morcellator assembly 1613 may then be disposed of whereasdrive assembly 1615 may be reused.

Referring now to FIG. 33, there is shown a fragmentary, partiallyexploded, perspective view of another alternate tissue removal deviceadapted for use in system 1007, said tissue removal device beingrepresented generally by reference numeral 1700. For simplicity andclarity, certain aspects of device 1700 not important to anunderstanding of the invention are neither shown nor described herein.

Device 1700 may comprise a morcellator assembly 1713 and a driveassembly 1715. Morcellator assembly 1713 and drive assembly 1715 may besimilar in many respects to morcellator assembly 1013 and drive assembly1015, respectively, the principal differences between the respectivemorcellator assemblies and drive assemblies being that (i) morcellatorassembly 1713 may be shaped to include a cavity 1717 and (ii) driveassembly 1715 may be shaped to be removably received within cavity 1717of morcellator assembly 1713. (Although not shown, morcellator assembly1713 and/or drive assembly 1715 preferably includes a mechanism forreleasably retaining drive assembly 1715 within cavity 1717.)Accordingly, when one wishes to use device 1700, drive assembly 1715 ispreferably inserted into cavity 1717 of morcellator assembly 1713 untilmorcellator assembly 1713 and drive assembly 1715 are physically andoperatively coupled to one another. Device 1700 may then be used in thesame manner discussed above in connection with device 1008. After device1700 has been used, drive assembly 1715 may be withdrawn from cavity1717 of morcellator assembly 1713. If desired, morcellator assembly 1713may then be disposed of whereas drive assembly 1715 may be reused.

Although the present invention has been discussed above in the contextof removing tissue from within a patient's uterus, it should beunderstood that there may be situations in which it may be desirable toremove fibroids or other tissue located on the exterior of a patient'suterus or elsewhere within a patient. In such situations, it may bedesirable to access the targeted tissue by laparoscopy. Unfortunately,however, one cannot simply apply suction in this type of case to drawthe tissue into the resection window of the device because the tissuewould not be bathed in a liquid, but rather, would simply be surroundedby air. Therefore, according to the present invention, one approach tothis problem is to deliver a suitable material to the targeted tissue,which may then be used, with the application of suction, to create aseal to promote the drawing of the targeted tissue into the resectionwindow of the device. Referring now to FIG. 34, there is shown anembodiment of a device designed for such a purpose, the device beingrepresented generally by reference numeral 1800. Certain aspects ofdevice 1800 not important to an understanding of the invention areneither shown nor described herein.

Device 1800 may be similar in certain respects to device 6. Onedifference between the two devices is that device 1800 may comprise aninner tubular member 1803 and an outer tubular member 1805. Innertubular member 1803 and outer tubular member 1805 may be similar toinner tubular member 77 and outer tubular member 76, respectively, ofdevice 6, except that (i) outer tubular member 1805 may comprise a port1807 adapted to receive a suitable liquid or gel (e.g., water, glycine,a thixotropic gel, etc.) from a supply (not shown) and (ii) innertubular member 1803 may have an outer diameter that is about 0.005-0.006inch less than the inner diameter of outer tubular member 1805 (asopposed to the about 0.002 inch of device 6) to permit the liquid or geldelivered to outer tubular member 1805 through port 1807 to be deliveredto the targeted tissue through a resection window 1809.

An alternate tissue removal device to device 1800 is shown in FIG. 35,said alternate tissue removal device being represented generally byreference numeral 1900. Certain aspects of device 1900 not important toan understanding of the invention are neither shown nor describedherein.

Device 1900 may be similar in most respects to device 6, the principaldifference between the two devices being that, whereas device 6 maycomprise outer tubular member 76, device 1900 may comprise an outertubular member 1903. Outer tubular member 1903 may be similar to outertubular member 76, except that outer tubular member 1903 may beadditionally shaped to include a channel 1905 having a proximal inputport 1907 and a distal output port 1909. Input port 1907 may be adaptedfor connection to a supply (not shown) for receipt of a suitable liquidor gel (e.g., water, glycine, a thixotropic gel, etc.). Distal port 1909may be positioned proximate to a resection window 1911.

The embodiments of the present invention described above are intended tobe merely exemplary and those skilled in the art shall be able to makenumerous variations and modifications to it without departing from thespirit of the present invention. All such variations and modificationsare intended to be within the scope of the present invention as definedin the appended claims.

1-2. (canceled)
 3. A uterine fibroid tissue removal device, comprising:a housing; an outer tube having a distal end and a proximal end, theproximal end of the outer tube supported by the housing, the outer tubeconfigured for transcervical insertion into a uterus and having a tissueresection window located proximate to the distal end of the outer tube,the tissue intake opening having a longitudinally oriented length. aninner tube disposed within the outer tube and configured to betranslated and rotated relative to the outer tube during operation ofthe tissue removal device; and a unitary distal tip member attached to adistal end of the inner tube such that the distal tip member translatesand rotates relative to the outer tube along with the inner tube duringoperation of the tissue removal device so that a distal facing opencutting end of the distal tip member in fluid communication with anaxial lumen of the distal tip member translates across the resectionwindow of the outer tube to sever tissue extending therethrough, thedistal tip member axial lumen being in fluid communication with an axiallumen of the inner tube, wherein the axial lumen of the distal tipmember is smaller in cross-sectional area than the axial lumen of theinner tube, and wherein the distal tip member has a length greater thana length of the resection window.
 4. The tissue removal device of claim3, wherein the length of the distal tip member is less than about 2inches.
 5. The tissue removal device of claim 3, wherein the length ofthe distal tip member is less than about 1 inch.
 6. The tissue removaldevice of claim 3, wherein the distal facing open cutting end of thedistal tip member comprises an external bevel.
 7. The tissue removaldevice of claim 6, wherein the external bevel comprises an angle ofabout 20 degrees.
 8. The tissue removal device of claim 3, wherein theinner tube is formed from a first material, and the distal tip member isformed from a second material harder than the first material.
 9. Thetissue removal device of claim 8, the second material comprising ahardness that exceeds the hardness of the first material by a Rockwell Chardness of at least about
 10. 10. The tissue removal device of claim 8,the second material comprising a Rockwell C hardness of at least about50.
 11. The tissue removal device of claim 3, wherein an outer diameterof the distal tip member is greater than an outer diameter of the innertube, such that an outer surface of the distal tip member acts as abearing surface against an inner surface of the outer tube duringoperation of the tissue removal device.
 12. The tissue removal device ofclaim 3, wherein the inner tube is sufficiently flexible to bend inconformity with a bend in the outer tube while rotating within the outertube.
 13. The tissue removal device of claim 3, further comprising: anintroducer device comprising an elongate sheath having an outer diameterof about 5.5 mm or less and comprising a first longitudinal lumenextending there through, at least a portion of the elongate sheath beingconfigured to enter a patient's uterus through the patient's cervix;wherein the outer tube has an outer diameter of less than about 5.5 mmand is configured to be received within the first longitudinal lumen.14. The tissue removal device of claim 3, further comprising: anintroducer device comprising an elongate sheath having an outer diameterand comprising a first longitudinal lumen extending there through, atleast a portion of the elongate sheath being configured to enter apatient's uterus through the patient's cervix; wherein the outer tubehas an outer diameter and is configured to be received within the firstlongitudinal lumen, and wherein a ratio of the outer diameter of thesheath to the outer diameter of the outer tube is less than about 2.1.